regulatory affairs director

AstraZeneca

<div>Job Title: Regulatory Affairs Director
Introduction to role:
Are you ready to shape regulatory strategy and policy to speed access to life-changing medicines? This role puts you at the heart of how our science reaches patients, turning complex regulatory landscapes into clear, forward-looking plans that enable confident, timely launches.
You will lead the regulatory agenda, influence authorities and external stakeholders while coaching a high-performing team. Can you see yourself setting the agenda with health authorities and industry bodies, then translating that influence into faster approvals and sustainable access? You will connect cross-functional teams, optimize processes, and turn insight into action&mdash;so patients benefit sooner.
Accountabilities:<ul><li>
Regulatory Strategy and Scorecard: Define and drive the regulatory strategy and scorecard in alignment with cross-functional teams and business priorities; translate strategy into measurable objectives that accelerate approvals and optimize launch readiness.</li><li>
Policy Shaping and External Influence: Lead policy-shaping initiatives; identify and progress collaborative projects with health authorities and external stakeholders that reduce barriers and clarify future pathways.</li><li>
Industry Representation and Advocacy: Actively represent AstraZeneca in relevant industry working groups; shape and lead the external policy agenda in line with company priorities to strengthen our voice and credibility.</li><li>
International Process and Systems Stewardship: Oversee InRex BCs processes in line with international guidance; ensure requirements are communicated to international teams and R3 is consistently updated to maintain high-quality regulatory data.</li><li>
Cross-Functional Leadership and Delivery: Lead or participate in global and regional delivery teams for complex submissions, providing expert regulatory advice and guiding health authority briefings to high-quality outcomes.</li><li>
Risk Management and Issue Resolution: Anticipate complex regulatory risks to operational plans and propose mitigation options that protect timelines and business objectives.</li><li>
Compliance and Governance: Lead GRP procedures and uphold all relevant AstraZeneca policies and cross-functional procedures; ensure disciplined execution throughout the registration lifecycle, including HAQ, through to approvals.</li><li>
Stakeholder Engagement: Build and maintain strong relationships with health officials and key external stakeholders to enable constructive dialogue, early insight, and predictable outcomes.</li><li>
Capability Building and Team Development: Uplift capabilities across the regulatory team; develop and coach colleagues, enhance ways of working, and contribute to a culture of continuous improvement and efficient operations.</li><li>
Intelligence and Communication: Keep leaders and stakeholders informed on registration status and regulatory changes at MOH; ensure timely, objective updates that support decision-making and alignment.</li></ul>
Essential Skills/Experience:<ul><li>
Advanced degree in life sciences, pharmacy, medicine, or a related discipline</li><li>
At Least 15 years&rsquo; Regulatory Experience</li><li>
Demonstrated success leading regulatory strategy across multiple therapeutic areas, including specialty products and high-volume launch environments</li><li>
Proven track record engaging senior health authority leaders and shaping external policy within complex political and healthcare ecosystems</li><li>
Strong negotiation, influencing, and storytelling skills to translate science into clear regulatory and policy narratives</li><li>
Experience implementing or optimizing regulatory information management systems and data quality standards</li><li>
Leadership with the ability to coach and build diverse, high-performing teams</li><li>
Experience managing end-to-end complex submissions, including scientific advice and briefing documents, with predictable timelines and outcomes</li><li>
Fluency in English</li></ul>
Desirable Skills/Experience:<ul><li>
Multinational experience</li><li>
Familiar with global pathways and ways of working</li></ul>
Why AstraZeneca:
Join a science-led company where regulatory experts are central to turning discovery into real-world impact. You will work with unexpected teams in the same room&mdash;clinicians, market shapers, data scientists, and policy leaders&mdash;unleashing bold thinking that clears the path for our innovative pipeline. We operate at pace with trust and empowerment, blending global scale with local agility to navigate evolving expectations and deliver sustainable access for patients. As we expand in specialty care and accelerate a high volume of launches, you will influence systems, not just submissions&mdash;growing your craft while advancing medicines that change lives. We value kindness alongside ambition, so you can lead with both courage and care.
Call to Action:
Step into a role where your regulatory leadership shapes access and outcomes&mdash;seize this opportunity to set the agenda and deliver faster approvals for patients.</div>

Regulatory Affairs Director, Egypt

American International University, Kuwait

<div>
 Reports to: Chief Executive Officer
 
 
 
 About The Role &ndash; Director Of Legal Affairs
 
 
 
 The Director of Legal Affairs serves as the University&rsquo;s chief legal authority and strategic advisor on all legal, regulatory, governance, and compliance matters. The role safeguards the institution&rsquo;s legal, financial, and reputational interests while ensuring full compliance with the laws and regulations of the State of Kuwait.
 
 
 As a senior member of the executive leadership team, the Director operates at the intersection of governance, operations, and institutional strategy&mdash;ensuring executive decisions are legally sound, risk-aware, and aligned with regulatory frameworks. The position requires sound judgment, discretion, and the ability to navigate complex institutional matters with professionalism and integrity.
 
 
 Participation in executive governance meetings and strategic institutional initiatives is expected.
 
 
 Duties and Responsibilities
 
 
 <ul>
 <li>
 Legal Advisory &amp; Institutional Governance
 </li>
 <li>
 Serve as principal legal advisor to the President, Executive Council, and Board of Trustees.
 </li>
 <li>
 Draft and review Board resolutions, executive directives, and institutional policies.
 </li>
 <li>
 Advise leadership on legal implications of strategic initiatives, restructuring, and institutional development.
 </li>
 <li>
 Ensure governance frameworks align with Kuwaiti legal and regulatory requirements.
 </li>
 <li>
 Attend executive and governance meetings as required.
 </li>
 <li>
 Contract Management &amp; Risk Mitigation
 </li>
 <li>
 Draft, review, and negotiate employment contracts and amendments.
 </li>
 <li>
 Review academic and administrative agreements.
 </li>
 <li>
 Oversee vendor, procurement, consultancy, and service contracts.
 </li>
 <li>
 Review and negotiate Memoranda of Understanding (MOUs) and partnership agreements.
 </li>
 <li>
 Identify legal risks and provide mitigation strategies.
 </li>
 <li>
 Establish and maintain standardized contract templates and legal review protocols.
 </li>
 <li>
 Maintain centralized legal documentation and contract governance oversight.
 </li>
 <li>
 Regulatory Compliance &amp; Government Liaison
 </li>
 <li>
 Ensure institutional compliance with:
 </li>
 <li>
 Kuwait Labor Law
 </li>
 <li>
 Ministry of Interior (MOI) regulations
 </li>
 <li>
 Public Authority for Manpower (PAM) regulations
 </li>
 <li>
 Residency and work permit regulations
 </li>
 <li>
 Higher education regulatory requirements
 </li>
 <li>
 Applicable data protection and privacy laws
 </li>
 <li>
 Liaise with government authorities, regulators, and external legal counsel as required.
 </li>
 <li>
 Oversee legal aspects of licensing, regulatory submissions, and institutional approvals.
 </li>
 <li>
 Employment &amp; Disciplinary Oversight
 </li>
 <li>
 Provide legal oversight on employee disciplinary matters, terminations, grievances, investigations, and misconduct cases.
 </li>
 <li>
 Ensure policy enforcement and compliance across the institution.
 </li>
 <li>
 Support HR leadership in complex or high-risk employment cases.
 </li>
 <li>
 Advise on legally compliant documentation and procedural processes.
 </li>
 <li>
 Litigation &amp; Dispute Management
 </li>
 <li>
 Manage external legal counsel and oversee litigation strategy.
 </li>
 <li>
 Lead institutional response to legal claims, disputes, and investigations.
 </li>
 <li>
 Provide recommendations on settlement negotiations and risk exposure.
 </li>
 <li>
 Maintain confidential legal records and case management documentation.
 </li>
 <li>
 Policy Development &amp; Institutional Protection
 </li>
 <li>
 Review and approve institutional policies prior to issuance.
 </li>
 <li>
 Ensure alignment between HR, Finance, Academic Affairs, and regulatory requirements.
 </li>
 <li>
 Develop standardized legal templates to minimize operational risk.
 </li>
 <li>
 Conduct periodic legal risk assessments for new initiatives and structural changes.
 </li>
 <li>
 Protect institutional intellectual property, trademarks, and brand integrity.
 
 
 </li>
 </ul>
 
 Minimum Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s Degree in Law (LLB) from a recognized institution.
 </li>
 <li>
 Master&rsquo;s Degree in Law (LLM) preferred.
 </li>
 <li>
 Legally qualified and admitted to practice law in a recognized jurisdiction.
 </li>
 <li>
 Minimum of 10&ndash;15 years of progressive legal experience.
 </li>
 <li>
 At least 5 years in a senior legal leadership role (Head of Legal / Legal Director / Senior Counsel).
 </li>
 <li>
 Strong working knowledge of Kuwaiti labor, commercial, and regulatory law.
 </li>
 <li>
 Experience within higher education or regulated institutions preferred.
 </li>
 <li>
 Demonstrated experience managing complex contracts and governance matters.
 </li>
 <li>
 Experience working within a multicultural and multi-linguistic environment.
 </li>
 <li>
 High level of discretion, integrity, and executive presence.
 
 
 </li>
 </ul>
 
 About American International University
 
 
 
 AIU is a new institution of higher education in Kuwait whose first student cohort was admitted in fall 2019. It is a private, coeducational institution offering undergraduate degrees based on the American model of higher education, including a comprehensive general education curriculum. Through its educational and student services programming, the University serves the intellectual, cultural, and personal growth of all members of its community. AIU offers degree programs in Film and Digital Media, Architecture, and Design, Engineering, and Business Administration where the language of instruction is English.
 
 
 For more information about AIU visit: www.aiu.edu.kw
 
 
 How to Apply
 
 
 To apply for this position, please visit the Job Opportunities section of our webpage and submit your resume, cover letter, and reel to: https://aiu.edu.kw/careers/jobs
</div>

Director of Legal Affairs

Tether Operations Limited

<div>Join Tether and Shape the Future of Digital Finance
At Tether, we&rsquo;re not just building products, we&rsquo;re pioneering a global financial revolution. Our cutting-edge solutions empower businesses&mdash;from exchanges and wallets to payment processors and ATMs&mdash;to seamlessly integrate reserve-backed tokens across blockchains. By harnessing the power of blockchain technology, Tether enables you to store, send, and receive digital tokens instantly, securely, and globally, all at a fraction of the cost. Transparency is the bedrock of everything we do, ensuring trust in every transaction.
Innovate with Tether
Tether Finance: Our innovative product suite features the world&rsquo;s most trusted stablecoin, USDT, relied upon by hundreds of millions worldwide, alongside pioneering digital asset tokenization services.
But that&rsquo;s just the beginning:
Tether Power: Driving sustainable growth, our energy solutions optimize excess power for Bitcoin mining using eco-friendly practices in state-of-the-art, geo-diverse facilities.
Tether Data: Fueling breakthroughs in AI and peer-to-peer technology, we reduce infrastructure costs and enhance global communications with cutting-edge solutions like KEET, our flagship app that redefines secure and private data sharing.
Tether Education: Democratizing access to top-tier digital learning, we empower individuals to thrive in the digital and gig economies, driving global growth and opportunity.
Tether Evolution: At the intersection of technology and human potential, we are pushing the boundaries of what is possible, crafting a future where innovation and human capabilities merge in powerful, unprecedented ways.
Why Join Us?
Our team is a global talent powerhouse, working remotely from every corner of the world. If you&rsquo;re passionate about making a mark in the fintech space, this is your opportunity to collaborate with some of the brightest minds, pushing boundaries and setting new standards. We&rsquo;ve grown fast, stayed lean, and secured our place as a leader in the industry.
If you have excellent English communication skills and are ready to contribute to the most innovative platform on the planet, Tether is the place for you.
Are you ready to be part of the future?
About the job
Tether and its affiliated entities (e.g. Bitfinex) are searching for an organized self-starter to join our Regulatory and Licensing team as Head of Licensing and Regulatory Authorisations. The successful candidate is someone with an understanding of the regulatory environment pertaining to the digital-asset industry / stablecoin industry, and who is excited by the opportunity to apply their existing legal and / or regulatory experience in an exciting and dynamic business environment.
The Head of Licensing and Regulatory Authorisations will lead the development and execution of our global authorisations strategy across key jurisdictions, working through a geographically distributed team of regional regulatory affairs and licensing teams. This role is responsible for securing and maintaining regulatory approvals required for the company&rsquo;s operations, ensuring alignment with shifting regulatory landscapes, and enabling sustainable market expansion.
As a senior leader within the Regulatory Affairs &amp; Licensing function, you will collaborate closely with regional licensing personnel, legal, compliance, product, and executive leadership to drive licensing initiatives end-to-end&mdash;from early regulatory assessments and submissions through to supervisory engagement and operational readiness. The ideal candidate brings deep multi-jurisdictional licensing expertise, exceptional stakeholder management skills, and the ability to coordinate across regions in a cohesive, consistent manner.
You will report to the Vice President of the Regulatory Affairs and Licensing division, and work alongside project managers and members of the wider business to execute on regulatory and licensing initiatives.
Responsibilities
Licensing Strategy &amp; Execution<ul><li>
Design and implement a unified global licensing strategy, ensuring consistency across regional approaches.</li><li>
Work closely with regional licensing personnel to assess regulatory pathways, evaluate market feasibility, and prioritise jurisdictions.</li><li>
Oversee and guide the preparation, submission, and management of licensing applications and / or other regulatory authorisation processes, in collaboration with regional teams.</li><li>
Ensure alignment between regional licensing efforts and global business priorities.</li></ul>
Regional Coordination &amp; Stakeholder Management<ul><li>
Serve as the central point of coordination for licensing and regulatory authorisation activity across all regions, ensuring standards, documentation, and approaches remain cohesive.</li><li>
Provide direct support, guidance, and escalation oversight to regional licensing personnel.</li><li>
Align regulatory authorisation efforts with regulatory affairs leads to coordinate regulatory engagement strategies across regions.</li></ul>
Regulatory Engagement<ul><li>
Act as a senior representative in regulatory engagements where global coordination or executive-level involvement is required.</li><li>
Support regional teams in interactions with local regulators, offering strategic guidance and ensuring consistent messaging.</li></ul>
Operational Readiness &amp; Governance<ul><li>
Coordinate with regional teams to ensure their understanding around local regulatory requirements such that they are prepared to meet jurisdictional authorisation obligations, where needed and / or desired, including governance, capital, operational, and reporting requirements.</li><li>
Maintain global oversight of regulatory authorisation conditions, ensuring local compliance is consistent with global policies and standards.</li><li>
Lead responses to cross-regional regulatory queries or supervisory reviews related to authorisation activities.</li></ul>
Market Expansion &amp; Risk Analysis<ul><li>
Work with regional personnel to conduct regulatory feasibility assessments for new markets and product expansions.</li><li>
Provide strategic recommendations to executive leadership on prioritisation of authorisation efforts and regulatory risk.</li></ul>
Team Leadership<ul><li>
Lead and mentor the global regulatory and licensing team, including regional leads and supporting personnel.</li><li>
Build capability, consistency, and knowledge-sharing across regions to strengthen the company&rsquo;s global licensing and authorisations function.</li><li>
Promote a culture of regulatory excellence, transparency, and disciplined execution.</li></ul> 
Experience &amp; Expertise<ul><li>
10+ years of experience in regulatory licensing and authorisations, regulatory affairs, compliance, or related fields (financial services, payments, fintech, crypto, or technology).</li><li>
Proven experience managing complex regulatory authorisation processes across multiple regions or markets.</li><li>
Strong understanding of diverse regulatory frameworks and supervisory expectations globally.</li><li>
Experience working within or leading a regional or matrixed team structure is highly preferred.</li></ul>
Skills &amp; Competencies<ul><li>
Exceptional cross-regional coordination and stakeholder engagement skills.</li><li>
Strong project management capabilities and ability to manage complex, multi-jurisdictional workstreams.</li><li>
Excellent written and verbal communication, able to synthesise regional inputs into a coherent global strategy.</li><li>
Strategic thinker with strong execution discipline.</li><li>
Ability to build trust and credibility with regulators and internal leadership.</li></ul>
Important information for candidates 
Recruitment scams have become increasingly common. To protect yourself, please keep the following in mind when applying for roles:<ul><li>
Apply only through our official channels. We do not use third-party platforms or agencies for recruitment unless clearly stated. All open roles are listed on our official careers page: https://tether.recruitee.com/</li><li>
Verify the recruiter&rsquo;s identity. All our recruiters have verified LinkedIn profiles. If you&rsquo;re unsure, you can confirm their identity by checking their profile or contacting us through our website.</li><li>
Be cautious of unusual communication methods. We do not conduct interviews over WhatsApp, Telegram, or SMS. All communication is done through official company emails and platforms.</li><li>
Double-check email addresses. All communication from us will come from emails ending in @tether.to or @tether.io</li><li>
We will never request payment or financial details. If someone asks for personal financial information or payment at any point during the hiring process, it is a scam. Please report it immediately.</li></ul>
When in doubt, feel free to reach out through our official website.</div>

Head of Licensing and Regulatory Authorisations

<div>Join Tether and Shape the Future of Digital Finance
At Tether, we&rsquo;re not just building products, we&rsquo;re pioneering a global financial revolution. Our cutting-edge solutions empower businesses&mdash;from exchanges and wallets to payment processors and ATMs&mdash;to seamlessly integrate reserve-backed tokens across blockchains. By harnessing the power of blockchain technology, Tether enables you to store, send, and receive digital tokens instantly, securely, and globally, all at a fraction of the cost. Transparency is the bedrock of everything we do, ensuring trust in every transaction.
Innovate with Tether
Tether Finance: Our innovative product suite features the world&rsquo;s most trusted stablecoin, USDT, relied upon by hundreds of millions worldwide, alongside pioneering digital asset tokenization services.
But that&rsquo;s just the beginning:
Tether Power: Driving sustainable growth, our energy solutions optimize excess power for Bitcoin mining using eco-friendly practices in state-of-the-art, geo-diverse facilities.
Tether Data: Fueling breakthroughs in AI and peer-to-peer technology, we reduce infrastructure costs and enhance global communications with cutting-edge solutions like KEET, our flagship app that redefines secure and private data sharing.
Tether Education: Democratizing access to top-tier digital learning, we empower individuals to thrive in the digital and gig economies, driving global growth and opportunity.
Tether Evolution: At the intersection of technology and human potential, we are pushing the boundaries of what is possible, crafting a future where innovation and human capabilities merge in powerful, unprecedented ways.
Why Join Us?
Our team is a global talent powerhouse, working remotely from every corner of the world. If you&rsquo;re passionate about making a mark in the fintech space, this is your opportunity to collaborate with some of the brightest minds, pushing boundaries and setting new standards. We&rsquo;ve grown fast, stayed lean, and secured our place as a leader in the industry.
If you have excellent English communication skills and are ready to contribute to the most innovative platform on the planet, Tether is the place for you.
Are you ready to be part of the future?
About the job
Tether and its affiliated entities (e.g. Bitfinex) are searching for an organized self-starter to join our Regulatory and Licensing team, to lead efforts in the Middle East. The successful candidate is someone with an understanding of the regulatory environment pertaining to the crypto-asset industry / stablecoin industry in the Middle East, and who is excited by the opportunity to apply their existing legal and / or regulatory experience in an exciting and dynamic business environment.
To succeed in this role, the incumbent will continuously strive to self-develop and enhance their skill sets including understanding the Company&rsquo;s products and services, blockchain technology, and regulatory requirements.
You will have a focus around working with regulators to translate policy objectives of the companies into favourable regulatory requirements in the region, as part of enabling the broader business strategy across Tether&rsquo;s business verticals.
The successful candidate should be comfortable managing relationships and communications between various stakeholders both internal and external to the business, including regulators and policy setters, as well as working with cross-functional teams such as Operations, Finance, Technology, Business Development.
You will report to the Vice President of the Regulatory and Licensing division, and work alongside project managers and members of the wider business to execute on regulatory affairs initiatives.
Responsibilities:
Regulatory Affairs<ul><li>
Monitor regulatory developments impacting Tether and affiliates companies in the region.</li><li>
Maintain active relationships with policymakers, regulators, central banks, and financial intelligence units.</li><li>
Represent the company in consultations, workshops, industry roundtables, and regulatory dialogues.</li><li>
Prepare briefing papers, comment letters, and policy submissions aligned with broader global regulatory strategy.</li><li>
Identify and successfully realise opportunities to shape emerging frameworks in a risk-sensitive, innovation-oriented manner.</li></ul>
Licensing &amp; Authorisations<ul><li>
Conduct structured assessments on whether licensing/registration is required for operations in the region.</li><li>
Working with your team and local advisor, you will be responsible for successfully obtaining regulatory authorisations in the region, where required.</li></ul>
Strategy &amp; Cross-Functional Collaboration<ul><li>
Support enterprise-level planning for new products or expansions in the region, advising on regulatory constraints and enablers to the Company&rsquo;s leadership.</li><li>
Contribute to internal reporting and executive briefings on policy risks and regulatory trajectory regionally.</li></ul> 
<ul><li>
Minimum of 8 years governmental affairs / regulatory affairs / legal experience ideally within the financial services or crypto-asset industry in the Middle East.</li><li>
Proven ability in successfully leading regulatory affairs teams within either the financial services industry, or the digital asset industry.</li><li>
Demonstrated experience working with regulators and government bodies advocating and advising in a regulatory capacity, with demonstrated achievements securing favourable policy positions on behalf of another organisation.</li><li>
Excellent written and verbal communication skills, with the ability to synthesise complex regulatory topics for non-technical audiences.</li><li>
Proven ability to manage multiple stakeholders across borders and time zones.</li><li>
Communication: Exceptional communication skills, both written and verbal, with experience in public speaking and representing companies in regulatory discussions.</li><li>
Must be a strong team player, and willing to be fully engaged with key stakeholders both in our company but also with our partners. Must be a hands-on professional capable of working collaboratively and independently.</li></ul>
Important information for candidates 
Recruitment scams have become increasingly common. To protect yourself, please keep the following in mind when applying for roles:<ul><li>
Apply only through our official channels. We do not use third-party platforms or agencies for recruitment unless clearly stated. All open roles are listed on our official careers page: https://tether.recruitee.com/</li><li>
Verify the recruiter&rsquo;s identity. All our recruiters have verified LinkedIn profiles. If you&rsquo;re unsure, you can confirm their identity by checking their profile or contacting us through our website.</li><li>
Be cautious of unusual communication methods. We do not conduct interviews over WhatsApp, Telegram, or SMS. All communication is done through official company emails and platforms.</li><li>
Double-check email addresses. All communication from us will come from emails ending in @tether.to or @tether.io</li><li>
We will never request payment or financial details. If someone asks for personal financial information or payment at any point during the hiring process, it is a scam. Please report it immediately.</li></ul>
When in doubt, feel free to reach out through our official website.</div>

Head of Regulatory Affairs and Licensing - Middle East

Mozart Therapeutics

<div>Description:

Mozart Therapeutics is an early clinical phase biopharmaceutical company located in Seattle, focused on developing novel immune engagers that specifically target a subset of T lymphocytes to delay the onset and ameliorate pathology of autoimmune diseases. We are developing first-in-class immune modulators that specifically target a novel regulatory T cell network. The company is seeking a highly motivated and experienced individual to join our team. The ideal candidate will work in a dynamic start-up environment to perform biorepository management of our clinical samples, collaborating with teams across the company, clinical trial sites, and laboratories. They will join a team focused on the discovery, generation, and development of therapeutic candidates in inflammatory and autoimmune disease. 
The VP, Global Regulatory Affairs will define and drive the global regulatory strategy for all Mozart programs. In this leadership role, you will design innovative, phase-appropriate regulatory pathways; lead major global submissions; and serve as the company&rsquo;s primary interface with regulatory authorities and partner organizations worldwide. Success looks like efficient development, strong compliance, and clear alignment with corporate objectives.
You will collaborate closely with Program Management, Clinical Development, Operations, Translational Medicine, Clinical Pharmacology, Nonclinical Toxicology, CMC, and Biostatistics to ensure scientific rigor, operational excellence, and regulatory success.
KEY RESPONSIBILITIES: 
Set the Strategy: Develop and execute integrated global regulatory strategies across all programs, optimizing for speed, risk mitigation, and approval readiness.
Own Submissions: Oversee the authorship, review, and delivery of core regulatory documents, including pre-IND and IND packages, Investigator&rsquo;s Brochures, clinical protocols and amendments, DSURs/PSURs, Clinical Study Reports, pediatric plans (as applicable), and global marketing applications.
Leadership: Lead interactions with FDA, EMA, PMDA, HREC and other global authorities; plan and conduct scientific advice/protocol assistance, and pre-submission meetings; ensure robust briefing packages and clear meeting outcomes.
Writing: Drive and participate in writing clinical trial documents, such as Investigator Brochures, Clinical Protocols and amendments, regular update reports (DSURs), Clinical study reports in collaboration with partners, CROs and internal project team.
Innovate Thoughtfully: Provide and execute innovative approaches to resolve complex regulatory issues and to increase speed to clinical trials for the good of patients.
Cross-Functional Partner: Partners with Clinical Pharmacology, CMC, Clinical Operations and Clinical Development to define and achieve product development objectives.
Quality &amp; Compliance: Partner with Quality Assurance to maintain robust, compliant quality systems and ensure regulatory strategies, submissions, and product development activities meet global quality and compliance standards.
Governance &amp; Communication: Present strategy, risk assessments, and decision points to executive leadership and governance committees; drive alignment and timely decisions.
Requirements:

KNOWLEDGE, SKILLS, AND ABILITIES:<ul><li>
Successful track record in the development of biologics for the treatment of inflammatory and autoimmune disease highly preferred. Experience with type-1-diabetes and/or inflammatory bowel disease strongly preferred.</li><li>
Successful track record of leading IND/CTA, NDA, and/or BLA submissions and engaging in the approval process.</li><li>
Extensive knowledge of clinical development, regulations of FDA, EMA, PMDA, HREC and international global clinical trial regulations</li><li>
Extensive experience in interactions with FDA, EMA, PMDA, CFDA.</li><li>
Working familiarity with innovative and adaptive clinical trial designs</li><li>
Knowledge of GxP regulations and ICH and FDA guidelines</li><li>
Experience in global submissions and approvals in Europe and Asia-Pacific</li><li>
Ability to blend analytical and critical thinking skills to enable data-driven, strategically oriented review of regulatory documents.</li><li>
Demonstrated leadership communication, analytic, problem-solving, organizational, and negotiation/decision-making skills.</li><li>
Nimble, creative, entrepreneurial with the ability to independently execute.</li><li>
Track record to collaborate with and mentor talents.</li><li>
Demonstrated ability to work in an innovative and fast-paced environment.</li><li>
A highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.</li></ul>
EDUCATION AND EXPERIENCE:<ul><li>
Ph.D., Pharm.D. or equivalent training in pharmaceutical sciences or a related field</li><li>
15 years' biopharmaceutical experience, including at least 10 years of direct experience in Regulatory Affairs and 5 years in a leadership role.</li></ul>
COMPENSATION &amp; BENEFITS:
The salary range is $288,000 min to $352,000 max. Fully qualified candidates will be paid in proximity to the salary mid-point. The wage range shown is based on the job posting&rsquo;s primary location. Actual compensation packages are based on a wide array of factors, including but not limited to skill set, experience, certifications, and location, in addition to internal equity and alignment with market data.
We offer our employees competitive compensation including annual performance bonuses and stock option grants. Benefits include paid vacation, sick leave, and holidays, medical, dental and vision insurance, life and long-term disability insurance, 401(k) with company matching. All benefits are non-contractual and may be amended, terminated, or enhanced as Mozart Therapeutics deems necessary.
Mozart is an equal opportunity employer. We encourage candidates from all backgrounds to apply and join us in our mission.</div>

Vice President, Global Regulatory Affairs

Boehringer Ingelheim

<div></div><div><div><div><div>As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. 
Provides new product and marketed product support in the Global Regulatory Affairs (RA) Chemistry Manufacturing and Controls (CMC) function for products in line with Company policies, business strategies and priorities in close collaboration with Quality, R&amp;D and Operations/Manufacturing. Responsible for the CMC technical information submitted to global Health Authorities supporting regulatory filings for assigned new pharmaceutical products and life cycle management of existing products in accordance with Company priorities and governance. Represents CMC through interactions with other RA groups, Analytical R&amp;D, Formulation Development, Quality and Operations on project teams. Accountable for new products in development and ongoing technical support to marketed products as it pertains to the preparation and maintenance of the CMC technical section of product applications and licenses worldwide. In collaboration with regional experts, develops strategies for innovative solutions and support systems, coordination of data to support CMC sections for worldwide registrations from early development, including supporting transfer of projects or existing products to new manufacturing sites, as well as assessing and maintaining product compliance with regulatory filings.
</div></div><div><div><h2 class="jobSectionHeader">Duties &amp; Responsibilities
</h2></div><div><ul><li>With a focus on USDA registration of animal health vaccines, direct the efforts of team members who are responsible for preparing, reviewing and filing regulatory submissions to global Regulatory Authorities.
</li><li>Ensure each team member is able to perform their job duties by providing leadership, mentoring, and development opportunities.
</li><li>Match projects with team members' experience level and skills ensuring that the objectives of the product team and company are met in the most efficient and compliant manner.
</li><li>Provide coaching, training and development to a group of regulatory professionals in order to provide solid succession planning for the future of the team. Incorporate performance and development plans with company goals in the HR management system.
</li><li>Define, plan and manage preparation of CMC submissions and support their approval by regulatory authorities. Provide support for international regulatory needs in alliance with global business partners and objectives.
</li><li>Direct activities needed to assess and resolve risks related to CMC, recommend actions and manage overall processes to provide guidance/direction/training to other departments relative to in-depth and current understanding of regulatory compliance, submission requirements, time lines or Regulatory Agency expectations.
</li><li>Assure regulatory compliance and interpretation of regulatory issues to assure excellence in R&amp;D and Manufacturing. Be part of a team with R&amp;D, Operations, QA, and Legal in assuring quality and compliance with Internal Manufacturing and third party manufacturers (CMOs).
</li><li>Provide guidance and consultation on product development, including active project team participation and support. Support business development opportunities through evaluation of potential licensing compounds and provide global CMC regulatory assessment.
</li><li>Provide guidance/direction within the regulatory department, to other departments and to internal and external manufacturing sites, relative to regulatory compliance of BIAH products and processes. Support manufacturing site inspections and provide leadership and advice to Operations and Quality in connection with authority inspections.
</li><li>Work with and develop professional relationships with regulatory agency contacts and regulatory groups; discuss and negotiate issues with regulatory agencies; act as primary liaison to Health Authorities and BI Regulatory Teams for foreign registrations; Establish collaborative and productive relationships with key functional players within Boehringer Ingelheim and CMOs. Understand/monitor regulatory trends and work with team to influence legislation/guidance and to inform organization of new guidelines, directives, and agency initiatives. Acts as RA Subject Matter Expert regarding legislation and guidelines.
</li><li>Proactively identify and initiate departmental process improvements, draft and review departmental processes and SOPs for activities relevant to this position and leads special projects as assigned.
</li><li>Promote a pro-active sense of ownership through agility, accountability and entrepreneurial action and mindset. Align with global, regional, and local regulatory objectives and execute as per plan.
</li></ul></div></div><div><div><h2 class="jobSectionHeader">Requirements
</h2></div><div><ul><li>An advanced degree in Life Sciences and/or degree in Life Sciences with relevant experience.
</li><li>Proven leadership, people development and management skills.
</li><li>More than 8 years of industry experience in a highly functioning position, conveying exposure to global
</li><li>Regulatory Authorities and Government Agencies.
</li><li>More than 5 years of direct CMC experience in a pharmaceutical field.
</li><li>Fluent in English.
</li><li>Regulatory certification or degree preferred
</li><li>Critical thinker with ability to self-manage workload
</li><li>Ability to work well under pressure, influence without decision-making authority, work in a team environment, flexibility to adapt in a changing environment.
</li><li>Detail oriented but also able to see &ldquo;big picture&rdquo;.
</li><li>Willing to travel, both domestic and internationally up to twenty (20) percent of the time
</li><li>Role model BI Values, by always doing what you say, and saying what you think.
</li><li>Make timely decisions with well-balanced analysis and intuition, particularly in tough situations.
</li><li>Ruthlessly prioritize, then drive execution excellence through discipline and collaboration.
</li><li>Actively give and seek feedback; leverage each other&rsquo;s strengths to deliver results and develop every individual.
</li><li>Search and respond to drivers of changes, through active experimentation.
</li><li>Challenge the status quo and assumptions of your own and others, with no political bias.
</li><li>Quickly turn data into insights and insights into actions.
</li><li>Learn with an open mind, and apply learnings from previous experiences.
</li><li>Serve the needs of customers and patients by turning innovative ideas into business results.
</li><li>Take smart risks by leveraging all possible opportunities, including resources and talents.
</li><li>Demonstrate winning spirit through creating a can-do attitude and positive energy among others.
</li>Deliver high quality results, despite challenging conditions. 
<li>
</li></ul>Eligibility Requirements:
<ul><li>Must be legally authorized to work in the United States without restriction
</li><li>Must be willing to take a drug test and post-offer physical (if required)
</li><li>Must be 18 years of age or older</li></ul></div></div></div></div>

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