associate director regulatory affairs

Perrigouk

Select how often (in days) to receive an alert: Associate Director - CMC Regulatory Affairs Location: London, GB, SW11 7BW; Dublin, IE, D02 TY74; Rotterdam, NL, 3062 CE; Ghent, BE, 9050; Chatillon, FR, 92320; Chatillon Cedex, FR, 92320At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill , Compeed , Solpadeine , NiQuitin , and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.Join us on our One Perrigo journey as we evolve to win in self-care. Description Overview As Associate Director, you will lead the development and execution of cutting-edge Chemistry, Manufacturing & Control (CMC) strategies, ensuring the highest standards of regulatory excellence across our diverse portfolio-from pharmaceuticals and medical devices to supplements, cosmetics, and beyond.You will contribute to the creation of robust quality dossiers and the seamless navigation and influencing of regulatory landscapes, turning challenges into opportunities for innovation and growth. By delivering timely submissions and proactively identifying risks and mitigation plans, you'll enable first-to-market approvals that enhance Perrigo's reputation as a global leader in CMC.You will inspire and empower a high-performing regulatory team, instilling a culture of agility, compliance, and continuous improvement. Scope of the Role <ul><li>Lead global CMC regulatory strategy and execution for innovation projects, post-approval changes, lifecycle management, and compliance across all product categories.</li><li>Oversee the preparation, review, and submission of high-quality CMC documentation (e.g., Module 3, Quality Overall Summary) for global health authority submissions, including new MAAs/NDAs/ANDAs, variations, renewals, and compliance updates.</li><li>Develop and implement response strategies for regulatory queries and deficiency letters related to CMC matters. Engage in technical discussions with Competent Authorities in partnership with Country Regulatory teams.</li><li>Collaborate with cross-functional teams to ensure regulatory CMC alignment with commercial strategy, manufacturing changes, and global supply continuity.</li><li>Manage CMC strategy and documentation for complex CMC projects, such as tech transfers, major reformulations and geo-expansion</li><li>Manage CMC risks associated with ingredient challenges and develop action plans to support defence, in partnership with Regulatory Product Stewardship team.</li><li>Monitor global CMC regulatory trends and new regulations and guidance. Provide product impact assessments and strategic guidance to ensure continued compliance and readiness for evolving requirements, in partnership with Regulatory Product Stewardship team.</li><li>Represent Perrigo in external regulatory forums and trade associations to advocate for CMC-related policy positions and regulatory best practices.</li><li>Build and lead a high-performing, globally distributed team with deep expertise in CMC</li><li>Foster a culture of excellence, agility, innovation, and continuous learning.</li><li>Develop talent pipelines and succession plans to ensure long-term organizational capability.</li></ul> Experience Required <ul><li>Advanced degree in Life Sciences (PhD, PharmD, MSc preferred).</li><li>15+ years of progressive experience including management roles in CMC</li><li>Proven track record of successful global submissions and approvals across diverse product categories.</li><li>Strong strategic, financial, and operational acumen.</li><li>Exceptional leadership, collaboration, and stakeholder engagement skills.</li><li>Experience with global regulatory systems and digital platforms.</li></ul> Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.Hybrid Working Approach We love our offices and the setting they provide for in-person collaboration and celebration. We also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more hereApplicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. <img src="https://www.jobg8.com/Tracking.aspx?HuNA3DPAJ8sb3AkohtyD6%2b1Ih9%2bnDZPTm" width="0" height="0" />

Associate Director - CMC Regulatory Affairs

Novartis Farmacéutica

Choose LocationChoose Location# Global Regulatory Affairs Associate Director (Cardio-Metabolic)REQ-Oct 14, 2025United Kingdom Summary (12 days per month on-site) Location: London (The Westworks), United Kingdom or Dublin, Ireland Internal Job Title: Global Program Regulatory Associate Director We are looking for an experienced and proactive Senior Global Program Regulatory Manager to join our Global Regulatory Affairs team.The role involves directing the development and submission of regulatory documents, providing strategic direction and negotiating with agencies to expedite approvals. It also ensures timely approval and compliance of new and marketed products, and serves as a regulatory liaison throughout the product lifecycle. About the Role Major accountabilities: Lead the implementation of regulatory strategies and operational activities across major global regions. Provide strategic input into global regulatory plans, identifying risks and contributing to key planning documents. Align regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams. Define and manage Health Authority (HA) interaction strategies, including preparation of briefing materials. Oversee the planning, coordination, and submission of regulatory dossiers (e.g., CTAs, INDs, Risk Management Plans). Serve as a liaison with local HAs (e.g., FDA, EMA) and lead or support negotiations for regional approvals. Develop and implement strategies to minimize review delays and regulatory clock stops. Ensure timely and compliant responses to HA queries and requests. Contribute to departmental goal setting and lead initiatives to improve regulatory processes. Ensure adherence to internal policies, SOPs, and global regulatory requirements. Minimum requirements: Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field. Significant experience in regulatory affairs within the pharmaceutical industry. Proven track record in project management and regulatory operations. Experience representing the organization in cross-functional and cross-cultural settings. Strong knowledge of clinical trials, drug development, and regulatory compliance. Excellent problem-solving, negotiation, and communication skills. Detail-oriented with the ability to manage complex regulatory projects. Skilled in risk management and working with cross-functional teams. Ability to navigate and influence Health Authority interactions. Fluency in English (written and spoken) is essential. Commitment to Diversity and Inclusion/EEO Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Why Novartis: Join our Novartis Network: Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally:DevelopmentUniversal Hierarchy NodeUnited KingdomLondon (The Westworks)GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.Research & DevelopmentFull timeRegularNoNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.REQ- Global Regulatory Affairs Associate Director (Cardio-Metabolic)<img src="https://www.jobg8.com/Tracking.aspx?n70Gs5vBCd8IWwUuLMXZlaNb9isvX8%2f5f" width="0" height="0" />

Global Regulatory Affairs Associate Director (Cardio-Metabolic)

Healthcare Businesswomens Association

Job Description Summary (12 days per month on-site) Location: London (The Westworks), United Kingdom or Dublin, Ireland Internal Job Title: Global Program Regulatory Associate Director Job Description We are looking for an experienced and proactive Senior Global Program Regulatory Manager to join our Global Regulatory Affairs team. The role involves directing the development and submission of regulatory documents, providing strategic direction and negotiating with agencies to expedite approvals. It also ensures timely approval and compliance of new and marketed products, and serves as a regulatory liaison throughout the product lifecycle. Major Accountabilities <ul> <li>Lead the implementation of regulatory strategies and operational activities across major global regions.</li> <li>Provide strategic input into global regulatory plans, identifying risks and contributing to key planning documents.</li> <li>Align regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams.</li> <li>Define and manage Health Authority (HA) interaction strategies, including preparation of briefing materials.</li> <li>Oversee the planning, coordination, and submission of regulatory dossiers (e.g., CTAs, INDs, Risk Management Plans).</li> <li>Serve as a liaison with local HAs (e.g., FDA, EMA) and lead or support negotiations for regional approvals.</li> <li>Develop and implement strategies to minimize review delays and regulatory clock stops.</li> <li>Ensure timely and compliant responses to HA queries and requests.</li> <li>Contribute to departmental goal setting and lead initiatives to improve regulatory processes.</li> <li>Ensure adherence to internal policies, SOPs, and global regulatory requirements.</li> </ul> Minimum Requirements <ul> <li>Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field.</li> <li>Significant experience in regulatory affairs within the pharmaceutical industry.</li> <li>Proven track record in project management and regulatory operations.</li> <li>Experience representing the organization in cross-functional and cross-cultural settings.</li> <li>Strong knowledge of clinical trials, drug development, and regulatory compliance.</li> <li>Excellent problem-solving, negotiation, and communication skills.</li> <li>Detail-oriented with the ability to manage complex regulatory projects.</li> <li>Skilled in risk management and working with cross-functional teams.</li> <li>Ability to navigate and influence Health Authority interactions.</li> <li>Fluency in English (written and spoken) is essential.</li> </ul> Commitment to Diversity and Inclusion/EEO Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Skills Desired <ul> <li>Clinical Trials</li> <li>Cross-Functional Teams</li> <li>Detail-Oriented</li> <li>Drug Development</li> <li>Lifesciences</li> <li>Negotiation SkillsProblem Solving SkillsRegulatory ComplianceRisk Management</li> </ul><img src="https://www.jobg8.com/Tracking.aspx?vAeLusD9WE0pILu4uWEJNiiMBr948H6fb" width="0" height="0" />

Amgen

<div>HOW MIGHT YOU DEFY IMAGINATION?
You&rsquo;ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission&mdash;to serve patients&mdash;drives all that we do. It is key to our becoming one of the world&rsquo;s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
CW Associate Regulatory Affairs - based in Dubai
Live
What you will do
Let&rsquo;s do this. Let&rsquo;s change the world. In this vital role, you will manage country-specific regulatory affairs for Amgen's molecules, coordinate and implement regulatory submissions, ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Manager's guidance :<ul><li>
Ensures regulatory submissions are made on time and meet Amgen&rsquo;s corporate and local regulatory requirements</li><li>
Reviews promotional and non-promotional materials.</li><li>
Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.</li><li>
Partners with International Regulatory Leads (IRLs) and Global Regulatory Leads (GRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.</li><li>
Partners with peers to ensure consistency on procedures.</li></ul>
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a teammate with these qualifications.
Basic Qualifications:<ul><li>
Bachelor`s degree in Pharmaceutical Science</li><li>
Working with policies, procedures and SOP&rsquo;s.</li><li>
Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.</li><li>
Knowledge of the Gulf legislation and regulations</li><li>
Understanding of regulatory activities and how they impact other projects and/or processes</li><li>
Understanding of drug development</li><li>
Demonstrate ability to work in teams</li><li>
Ability to understand and communicate scientific/clinical information</li></ul>
Preferred Qualifications:<ul><li>
Regulatory experience of the Gulf Markets</li><li>
Knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets.</li><li>
Experience interacting with regulatory agency in the Gulf markets</li></ul>
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates&rsquo; professional and personal growth and well-being.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.</div>

Associate Regulatory Affairs - based in Dubai

Human Capital HR Solutions

The Assistant Manager &ndash; Regulatory &amp; Corporate Affairs will ensure full compliance with all statutory and regulatory requirements while supporting the company&rsquo;s legal, licensing, and corporate governance activities. The role requires close coordination with internal departments, legal counsel, and government authorities to maintain a compliant and well-governed business environment.Key Responsibilities:<ul><li>Ensure compliance with local laws, regulatory bodies, and industry standards.</li><li>Manage regulatory filings, licenses, renewals, and statutory documentation.</li><li>Liaise with government departments, legal advisors, and industry associations.</li><li>Support corporate documentation, board meetings, and policy development.</li><li>Prepare and review contracts, agreements, and legal correspondences.</li><li>Facilitate internal and external audits conducted by regulatory authorities.</li><li>Monitor and report on new or updated regulations affecting company operations.</li></ul>Job Type: Full-timePay: Rs120,000.00 - Rs170,000.00 per monthWork Location: In person

Assistant Manager – Regulatory & Corporate Affairs

American Career College

Reporting to the University Director Student Affairs, the Associate University Director, Student Rights & Responsibilities collaborates with university leadership to enhance the student experience across all campuses and online programs. This role focuses on implementing and evaluating initiatives that support student mental and physical well-being, increasing awareness and access to Accessibility Services, and promoting understanding of academic and behavioral conduct standards. The Associate Director also plays a key role in addressing student grievances and complaints and provides support for Title IX compliance. Additional responsibilities include reviewing and revising policies and processes, developing training for students and staff, establishing measurable outcomes and assessment methods, and preparing an annual strategic work plan and budget. The Associate Director chairs the Student Success and Wellness Subcommittee and ensures institutional compliance with all relevant regulatory and accrediting bodies.Essential Functions & Responsibilities:<ul><li>Provides leadership and daily oversight of Student Rights and Responsibilities operations and activities related to comprehensive initiatives in support of student mental/physical wellness, accessibility services, grievances, student academic and behavioral conduct.</li><li>Serve as backup to University Director of Student Affairs when the University Director is out of office; serve as proxy for University Director of Student Affairs for required signatures and for decisions related to escalated student/campus issues, active initiatives, budget, personnel, etc.</li><li>Serve as chair for the Student Success and Wellness Subcommittee of the University Student Advisory Committee; oversee and ensure Student Rights and Responsibilities compliance with all regulatory agencies, state and governing boards and accrediting bodies, including but not limited to the Jeanne Cleary Act, ADA, Title IX, ACICS, WASC, and BPPE.</li><li>Develop engaging Campus Support Services-sponsored student events/activities and WCU-wide support resources (both on ground and online) in support of student mental/physical wellness, Accessibility Services, student academic and behavioral conduct. Create annual event calendar; collaborate with Student Communications and Social Media teams to promote and build awareness.</li><li>Serve as subject matter expert (SME) for Student Rights and Responsibilities-related information; lead development of online training modules for students, faculty, and associates on student mental/physical wellness, Accessibility Services, and student academic and behavioral conduct.</li><li>Work closely with the University Director of Student Affairs to develop annual strategic work plans, outlining goals, timelines/schedules for deliverables, resource needs, and plans for assessment.</li><li>Develop annual Student Rights and Responsibilities operating budget requests for review by the University Director of Student Affairs.</li><li>Advise University Director of Student Affairs on related administrative policy/process needs, draft new or revised policies and processes and shepherd through appropriate review and approval channels.</li><li>Collaborate with University stakeholders including but not limited to the Director of the Center for Excellence in Teaching and Learning, Human Resources, and Campus Executive Directors/Deans/Directors of Student Affairs to embed Rights and Responsibilities content into annual WCU Academic Conferences, faculty training, and student orientations, etc.</li><li>In partnership with the University Director of Student Affairs, establish measurable and actionable standards, outcomes, and KPIs; develop effective assessment methods for all initiatives.</li><li>Develop and maintain strong collaborative partnerships between WCU University Student Affairs, Campus Support Services and Campus stakeholders including but not limited to students, faculty, associates, Campus Executive Directors, and Campus Directors of Student Affairs.</li><li>Draft content for internal and external communications; maintain and keep current the library of templates for conduct communications; review Student Rights and Responsibilities-related content for Gabby chatbot; maintain and enhance Student Rights and Responsibilities-related areas of student portal, student catalog, and University website; establish cadence for regular reviews and updates to ensure information is always current for students, faculty, and associates.</li><li>Prepare complex qualitative and quantitative reports; proactively monitor and report on student outcomes specific to Student Rights and Responsibilities; prepare trend analyses indicating variances over time to be used in strategic decision making/planning.</li><li>Ensure the maintenance and accuracy of student records in systems utilized by the Student Affairs; proactively identify and troubleshoot issues with IT partners.</li><li>Maintain an understanding of relevant research on student mental/physical wellness, student accessibility, and student academic/behavioral conduct; participate in and consult with national higher education associations related to areas of oversight; attend and/or present at conferences to stay current on best higher-education practices; contribute to scholarship in the field.</li><li>Maintain and protect confidentiality of all student, associate, and/or University information as required.</li><li>Adhere to University policies and procedures and conduct job responsibilities in accordance with the standards set out in the University's Code of Ethical Conduct, Compliance Agreement, Sexual Harassment Policy (or any related policies and procedures), applicable federal and state laws, and applicable professional standards.</li><li>Represent Student Affairs on assigned task forces, committees, and work groups.</li><li>Actively contribute to a supportive and fun work environment; model values of teamwork and shared success across all units under Student Affairs.</li><li>Must be willing to work occasional evening and weekend hours and be flexible to adjust schedule as needed to best meet student and team needs and availability; occasional travel to California, Florida, and Texas campuses is required.</li><li>Demonstrate advanced skills in delivering sound judgment and accurate, thorough work, in the midst of competing priorities and frequent interruptions and demands for time.</li><li>Actively participate as a member of the Campus Support Services Leadership Team.</li></ul>Education, Experience & Skills:<ul><li>Master's Degree required in College Student Personnel, Education, Student Affairs, Counseling, or related field.</li><li>Current non-commercial driver's license.</li><li>Minimum of five years of progressively responsible management-level experience working in an institution of higher education in the areas of accessibility services, judicial affairs/Title IX, student affairs, student administration, student support services. Additional experience working with nursing and health sciences students preferred but not required.</li><li>Experience with regulatory and contractual compliance preferred.</li><li>Demonstrated understanding of trends and best practices in the areas of student mental/physical wellness, student accessibility, and student academic/behavioral conduct, and their impact on student persistence/retention; extensive knowledge of University policies and processes related to student accessibility, student conduct and rights, and Title IX.</li><li>Knowledge of state, federal and local laws/regulations relating to programs, governmental compliance, and other regulatory standards such as Title IX, ACICS, WASC, BPPE and other accreditation standards.</li><li>Ability to conduct interviews and investigations using trauma-informed techniques when appropriate.</li><li>Knowledge of crisis intervention and advocacy principles and practices; demonstrated experience in effectively de-escalating student concerns or behavioral issues and/or adeptly handling students not responding to de-escalation attempts.</li><li>Strong ability to assess a situation quickly, demonstrate good judgment, and resolve issues; keen ability to balance the needs of the student/associate/faculty with the business of the University.</li><li>Ability to develop and present educational programs and/or workshops, both on ground and online.</li><li>Strong supervisory experience; hiring, training, coaching, assessing; ability to hold difficult performance-related conversations effectively and to handle performance issues quickly and decisively with compassion.</li><li>Keen ability to examine and reengineer operations and procedures, formulate policy, and develop and implement best practices.</li><li>Evidence of experience assessing efficacy of student support resources and programs; report writing; strong judgment, problem-solving, and creative-thinking skills.</li><li>Demonstrated ability to lead decisively while allowing space for stakeholder feedback and ideas; keen instincts on when to build consensus and when to move swiftly to achieve desired outcomes.</li><li>Ability to work with diverse populations and sensitivity to economic, cultural, and other issues related to persistence and retention of a diverse student population.</li><li>Proven working experience with MSOffice, student information systems, Maxient, reporting tools, and communication technologies (including SMS and chat).</li><li>Exercises care, proper use and maintenance of department equipment and supplies and identifies unsafe conditions and makes appropriate adjustments.</li></ul>Campus: Administration Irvine Function: Leadership<img src="https://www.jobg8.com/Tracking.aspx?qn2dWMJXE5Plz%2b%2bNi4tiFu4zxQx7aZ%2fNq" width="0" height="0" />

Associate University Director, Student Rights & Responsibilities

<ul><li>Ensure full compliance with all applicable regulatory and statutory requirements.</li><li>Manage regulatory filings, licenses, renewals, and other corporate documentation.</li><li>Liaise with government departments, external agencies, and industry associations.</li><li>Support the preparation and review of legal documents, contracts, and governance records.</li><li>Coordinate and manage internal and external audits from regulatory agencies.</li><li>Monitor, interpret, and report on new regulations impacting the automotive industry.</li></ul>Job Type: Full-timePay: Rs160,000.00 - Rs230,000.00 per monthWork Location: In person

Assistant Manager (Regulatory & Corporate Affairs)

Search 10000+ Associate director regulatory affairs jobs near you this October. New roles added regularly across leading industries. Apply today.

10000 associate director regulatory affairs jobs NEAR_ME

Associate Director - CMC Regulatory Affairs

Global Regulatory Affairs Associate Director (Cardio-Metabolic)

Global Regulatory Affairs Associate Director (Cardio-Metabolic)

Associate Regulatory Affairs - based in Dubai

Assistant Manager – Regulatory & Corporate Affairs

Associate University Director, Student Rights & Responsibilities

Assistant Manager (Regulatory & Corporate Affairs)