senior regulatory affairs specialist

Thermo Fisher Scientific

<div><p><b>Work Schedule</b></p>
Standard Office Hours (40/wk)<p></p><p><b>
Environmental Conditions</b></p>
Office<p></p><p><b>
Job Description</b></p><p></p><p>
At Thermo Fisher Scientific, you&rsquo;ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our colleagues with the resources needed to achieve career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on &ndash; now and in the future.</p><p></p><p><b>
Location/Division Specific Information</b></p><p>
Our PPD&reg; part of Thermo Fisher Scientific team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our Clinical Operations professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.</p><p></p><h2 class="jobSectionHeader"><b>
Discover Impactful Work:</b></h2><p>
Serves as a senior contact within the Middle East Clinical Operations at CRG, Thermo Fisher Scientific, providing innovative solutions and regulatory expertise. Interacts with clients to offer strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization, ensuring compliance with regulatory bodies in the middle east. Provides strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements. Acts as a liaison with internal and external clients in the provision and marketing of these specialized regulatory services.</p><p></p><h2 class="jobSectionHeader"><b>
A day in the Life:</b></h2><ul><li>
Prepares and reviews regulatory submissions.</li><li>
Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in executing strategies.</li><li>
Leads the development and implementation of project-specific processes for sponsors.</li><li>
Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.</li><li>
Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.</li><li>
Provides training and guidance to junior team members as appropriate.</li><li>
Participates in project launch meetings, review meetings and project team meetings.</li><li>
Supports business development activities, including project budgeting/forecasting</li></ul><p></p><h2 class="jobSectionHeader"><b>
Keys to Success:</b></h2><p></p><p><b>
Mandatory requirements</b></p><ul><li><p>
Saudi Arabia National</p></li><li><p>
Native Arabic speaker</p></li><li><p>
Willingness to be based in Riyadh</p></li></ul><p><b>
Knowledge, Skills, Abilities</b></p><ul><li>
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).</li><li>
Bachelor's degree or equivalent and relevant formal academic / vocational qualification</li><li>
Strong English language (written and oral) communication skills as well as local language where applicable</li><li>
Solid understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; good knowledge of ICH and other global regulatory guidelines; basic understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.</li><li>
Solid understanding of medical terminology, statistical concepts, and guidelines</li><li>
Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables</li><li>
Solid attention to detail and quality as well as strong editorial/proofreading skills</li><li>
Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments</li><li>
Solid computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies</li><li>
Solid organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects</li><li>
Solid negotiation skills</li><li>
Strong analytical, investigative and problem-solving skills</li><li>
Working knowledge of budgeting and forecasting&quot;</li></ul><p></p><h2 class="jobSectionHeader"><b>
Work Environment
</b></h2><p></p><p>Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:</p><p></p><ul><li>
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.</li><li>
Able to work upright and stationary for typical working hours.</li><li>
Ability to use and learn standard office equipment and technology with proficiency.</li><li>
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.</li><li>
May require travel.</li></ul><p></p><h2 class="jobSectionHeader"><b>
Benefits</b></h2><p></p><p>
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!</p></div><p></p>

Senior Regulatory Affairs Specialist - GCL

Novonesis

<div><p><b>Are you ready for a new beginning?
</b></p><p>We need your talent, knowledge and dedication to better our world with biology.
</p><p></p><p><b>Our purpose points the way
</b></p><p>In Novonesis, we know that solutions rooted in biology can help solve humanity&rsquo;s biggest challenges. Since we began more than a century ago, this has been our guide. It&rsquo;s how we've gotten so far. And it&rsquo;s how we'll impact the future. Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless.
</p><p></p><p><b>We&rsquo;re here to better our world with biology.
</b></p><p></p><h1 class="jobSectionHeader"><b>Job Description: Senior Regulatory Affairs Specialist &ndash; Dubai
</b></h1><p>Location: Dubai, UAE
</p><p>Department: Regulatory Affairs, MEIA Region
</p><p>Reports to: Head of Regulatory Affairs &ndash; MEIA
</p><p>Job Type: Full-time
</p><p></p><h2 class="jobSectionHeader"><b>About Novonesis
</b></h2><p>At Novonesis, we are committed to unlocking the power of biosolutions to create a better world. Our People &amp; Organization (P&amp;O) culture is built on care, impact, ownership, and exploration. We believe in empowering our people to thrive and make a difference.
</p><h2 class="jobSectionHeader"><b>Purpose of the Role
</b></h2><p>As the Senior Regulatory Affairs Specialist, you will be responsible for ensuring regulatory compliance and enabling market access for Novonesis products across the MEA region. You will lead regulatory strategies, manage submissions, and maintain strong relationships with local authorities and internal stakeholders to support business growth.
</p><h2 class="jobSectionHeader"><b>Key Responsibilities
</b></h2><ul><li><ul><li>Regulatory Strategy &amp; Compliance
</li></ul></li><li><ul><li>Dossier Preparation &amp; Submission
</li></ul></li><li><ul><li>Stakeholder Engagement
</li></ul></li><li><ul><li>Regulatory Intelligence &amp; Risk Management
</li></ul></li><li><ul><li>Regulatory advice to business
</li></ul></li></ul><h2 class="jobSectionHeader"><b>Qualifications &amp; Experience
</b></h2><ul><li><ul><li>Bachelor&rsquo;s or Master&rsquo;s degree in Life Sciences, Pharmacy, or related field.
</li></ul></li><li>Arabic or French Language knowledge is Mandatory
</li><li>Minimum 7-10 years of experience in Regulatory Affairs within the pharmaceutical, biotech, or biosolutions industry.
</li><li><ul><li>Proven track record of successful regulatory submissions and approvals.
</li></ul></li><li><ul><li>Strong knowledge of local and regional regulatory frameworks.
</li></ul></li><li><ul><li>Excellent communication and project management skills.
</li></ul></li></ul><h2 class="jobSectionHeader"><b>Preferred Attributes
</b></h2><ul><li><ul><li>Experience working in a matrixed, multicultural environment.
</li></ul></li><li><ul><li>Ability to work independently and take ownership of projects.
</li></ul></li><li><ul><li>Passion for innovation and sustainability in biosolutions.
</li></ul></li></ul><h2 class="jobSectionHeader"><b>Why Join Us?
</b></h2><ul><li><ul><li>Be part of a purpose-driven company shaping the future of biosolutions.
</li></ul></li><li><ul><li>Work in a collaborative and inclusive environment that values your growth.
</li></ul></li><li><ul><li>Make a tangible impact in the MEIA region and beyond
</li></ul></li></ul><p></p><p><b>Could our purpose be yours? </b><b>Then apply today!
</b></p><p></p><p>At Novonesis we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We recommend you not to attach a cover letter to your application. Instead, please include a few sentences in your resume/CV about why you are applying. To ensure a fair recruitment process, please refrain from adding a photo in your resume/CV.
<br>
<br>
Novonesis is dedicated to fostering a unique community by embracing and respecting differences. We make all employment decisions based on business needs, ensuring that every individual can thrive, regardless of identity or background such as ethnicity, religion, gender, sexual orientation, age, disability, or veteran status.
<br>
<br>
<b>Want to learn more?
</b><br>
Learn more about Novonesis, our purpose, and your career opportunities at novonesis.com
<br>
<br>
<b>Not the right fit for you?
</b><br>
Even if this job isn't the right fit for you, perhaps you know someone who might find it interesting. If so, please feel free to share the job link and encourage them to apply. Thank you for your referral! Please check out our other open positions. The right fit for you could just be a few clicks away.
</p><p></p><p><b>Stay alert: Avoid recruitment scams
</b><br>
At Novonesis, we are committed to maintaining a safe and transparent recruitment process. Please be aware of potential scams targeting job seekers and take note of the following:
</p><ul><li><i>Novonesis will never ask for sensitive personal information, such as bank account details, Social Security numbers, or passwords, at any stage of the hiring process.
</i></li><li><i>Novonesis does not make employment offers without conducting interviews with candidates.
</i></li></ul><p></p><p><i>If you receive suspicious communication claiming to be from Novonesis, please do not share any personal or financial information. </i><i>We encourage you to verify the legitimacy of the message by contacting us directly through our official channels.</i></p></div><p></p>

Senior Regulatory Specialist

Johnson & Johnson

<div><p>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com</p><p><b>
Job Function:
</b></p>Regulatory Affairs Group<p><b>
Job Sub Function:
</b></p>Regulatory Product Submissions and Registration<p><b>
Job Category:</b></p>
Professional<p><b>
All Job Posting Locations:</b></p>
Riyadh, Saudi Arabia<p><b>
Job Description:</b></p><p><b>
About MedTech</b></p><p>
Fueled by innovation at the intersection of biology and technology, we&rsquo;re developing the next generation of smarter, less invasive, more personalized treatments.</p><p>
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech</p><p><b>
REGULATORY AFFAIRS SPECIALIST (MEDICAL DEVICES)</b></p><p><b>
Location: Riyadh</b></p><p><b>
Contract: full-time</b></p><p><b>
Purpose:</b></p><p>
The main task of a Regulatory Affairs specialist in Johnson &amp; Johnson is Launching of Medical Device Products in Saudi Arabia Market in compliance with the Regulatory registration &amp; importation guidance.</p><p><b>
You will be responsible for:</b></p><ul><li>
Preparing, compiling and submission of registration/ re-registration products files in addition to variation submission on time directly in Saudi Arabia or through J&amp;J distributors when applicable</li><li>
SFDA meetings</li><li>
Clearance support to distributors</li><li>
Updating the regulatory tracking systems</li><li>
Having the renewed certificates &amp; re-registration licenses of expired ones on time</li><li>
Responding to Change Impact Assessments before due dates</li><li>
Doing Copy Review process for promotional materials on time upon request</li><li>
Lift all regulatory restrictions for products that can be shipped to Saudi Arabia</li><li>
Tender support to commercial teams &amp; distributors</li></ul><p><b>
Qualifications / Requirements:</b></p><ul><li>
Education: Bachelor&rsquo;s (B.Sc.) degree of Biomedical engineering or Sciences</li><li>
Minimum 2 years of Regulatory Affairs experience withing Medical Devices industry</li><li>
Language: English &amp; Arabic (fluent)</li><li>
Time Management</li><li>
Very good presentation &amp; communication skills</li><li>
Sense of urgency, attention to details, creative problem-solving</li><li>
Collaboration &amp; teamwork</li><li>
Self-motivation, ability to work under stress</li><li>
Involvement in Regional Projects</li><li>
Saudi national</li></ul></div>

Regulatory Affairs Specialist (medical devices)

<div><h1 class="jobSectionHeader"><b>Job Description Summary</b></h1>
An excellent opportunity in the regulatory affairs team within BD, the role is to be based in Cairo and will be a fixed term contract for 1 year.<p></p><h1 class="jobSectionHeader"><b>
Job Description</b></h1><h1 class="jobSectionHeader"><b>
We are the makers of possible</b></h1><p></p><p>
BD is one of the largest global medical technology companies in the world. Advancing the world of health&trade; is our Purpose, and it&rsquo;s no small feat. It takes the imagination and passion of all of us&mdash;from design and engineering to the manufacturing and marketing of our billions of MedTech products per year&mdash;to look at the impossible and find transformative solutions that turn dreams into possibilities.</p><h1 class="jobSectionHeader"><b>
Why join us?</b></h1><p></p><p>
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.</p><p></p><p>
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you&rsquo;ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.</p><p></p><p>
Become a <b>maker of possible </b>with us!</p><h2 class="jobSectionHeader"><b>
About the role
</b></h2><p>The Regulatory Affairs Specialist plays a key role in ensuring compliance of promotional materials with regulatory standards across the EMEA region. As a member of EMEA Regulatory Business Solutions team, you will support the review and approval of promotional content, manage technical documentation, and drive continuous improvement initiatives within regulatory processes.</p><h2 class="jobSectionHeader"><b>
Main responsibilities will include:</b></h2><ul><li>
Regulatory review and approval of promotional materials (Ad Prom)</li><li>
Conduct thorough regulatory reviews of promotional and advertising materials to ensure compliance with applicable laws, guidelines, and internal policies.</li><li>
Collaborate with cross-functional teams including Marketing, Medical Affairs, and Legal to facilitate timely approvals.</li><li>
Actively contribute to the development and implementation of best practices within the Ad Prom COE (Center of Excellence)</li><li>
Review and approve Technical Data Sheets (TDS) in alignment with product specifications and regulatory requirements.</li><li>
Ensure accuracy and consistency of technical documentation across platforms.</li></ul><h2 class="jobSectionHeader"><b>
About you</b></h2><ul><li>
Bachelor&rsquo;s degree in Life Sciences, Pharmacy, or a related healthcare field.</li><li>
Experience in regulatory affairs, preferably within the medical device or pharmaceutical industry.</li><li>
Excellent communication, organizational, and analytical skills.</li><li>
Proficiency in English; additional languages are a plus</li></ul><h2 class="jobSectionHeader"><b>
Click on apply if this sounds like you!</b></h2><p></p><p>
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.</p><p></p><p>
Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.</p><h2 class="jobSectionHeader"><b>
To learn more about BD visit: </b><b>https://bd.com/careers</b></h2><p></p><p>
Required Skills</p><p>
Optional Skills</p><p></p><p>
.</p><h1 class="jobSectionHeader"><b>
Primary Work Location</b></h1>
EGY - Cairo<p></p><h1 class="jobSectionHeader"><b>
Additional Locations</b></h1><p></p><h1 class="jobSectionHeader"><b>
Work Shift</b></h1></div>

Regulatory Affairs Specialist (Fixed term contract for 1 year)

SOLARIAN ASTRA PVT LTD

<div>
 <p>
  <strong>
   Job Title: Senior Manager &ndash; Regulatory Affairs
  </strong>
 </p>
 <p>
  <strong>
   Company: Solarian Astra Pvt. Ltd.
  </strong>
 </p>
 <p>
  <strong>
   Location: Noida, India | Hybrid
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   About Solarian Astra
  </strong>
 </p>
 <p>
  Solarian Astra Pvt. Ltd. is a leading one-stop solution for solar projects, covering the entire lifecycle from planning and land acquisition to EPC, commissioning, regulatory approvals, charging, and maintenance. We deliver integrated, end-to-end solutions for solar projects across India, combining technical excellence with a commitment to sustainable, reliable energy. We foster a diverse, inclusive, and high-performance work culture focused on innovation and impact.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Role Overview
  </strong>
 </p>
 <p>
  The Senior Manager &ndash; Regulatory Affairs will monitor and analyze regulatory and policy developments in the renewable energy sector, prepare internal advisories, and support policy advocacy initiatives. This role includes engaging in external meetings, conducting in-depth research, documentation, and compliance tracking to ensure project readiness and timely submissions.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Key Responsibilities
  </strong>
 </p>
 <p>
  <strong>
   1. Regulatory Tracking &amp; Analysis
  </strong>
 </p>
 <ul>
  <li>
   Monitor notifications, orders, and regulations from CERC, SERCs, MNRE, MoP, CTUIL, CSTUs/CTUs, state energy commissions, and other authorities; synthesize implications for the business.
  </li>
  <li>
   Develop detailed PowerPoint presentations on new policies, rules, and regulations for internal use and leadership reviews.
  </li>
  <li>
   Prepare clear, concise summaries and impact notes for cross-functional teams.
  </li>
 </ul>
 <p>
  <strong>
   2. Documentation &amp; Drafting
  </strong>
 </p>
 <ul>
  <li>
   Draft consultation responses, regulatory submissions, and briefing materials for review by the Head of Regulatory Affairs.
  </li>
  <li>
   Maintain a centralized repository of policy documents, past submissions, and regulatory correspondence.
  </li>
  <li>
   Prepare formats and letters required for permits, approvals, and authorizations.
  </li>
  <li>
   Develop and maintain energy cost sheets and models (e.g., Captive, Group Captive, Third-Party PPA structures) for financial planning and feasibility analyses.
  </li>
 </ul>
 <p>
  <strong>
   3. Compliance Support
  </strong>
 </p>
 <ul>
  <li>
   Maintain trackers for statutory filings, licenses, and regulatory obligations across projects.
  </li>
  <li>
   Alert relevant teams to upcoming deadlines and regulatory changes.
  </li>
  <li>
   Manage statutory clearances, liaising with appropriate authorities and internal stakeholders.
  </li>
  <li>
   Coordinate permissions and approvals (e.g., RLDC, PTCC, CEIG, Section-64, Section-168, transmission/line crossing, grid connectivity, National/State Highway crossing, NOCs from civil aviation, forest, pollution control boards, and other sectoral centre or state regulators) as applicable to projects.
  </li>
 </ul>
 <p>
  <strong>
   4. Internal Coordination
  </strong>
 </p>
 <ul>
  <li>
   Liaise with Legal, Project, Finance, and Business teams to collect inputs for regulatory submissions.
  </li>
  <li>
   Provide regulatory references to support project development, bidding, and commercialization strategies.
  </li>
  <li>
   Facilitate cross-functional review of regulatory documents to ensure accuracy and alignment with business objectives.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Qualifications
  </strong>
 </p>
 <p>
  <strong>
   Educational Requirements
  </strong>
 </p>
 <ul>
  <li>
   Bachelor&rsquo;s degree in Engineering, Economics, Law, Public Policy; MBA in Power Management/Energy Management preferred.
  </li>
  <li>
   Advanced degree or professional certifications in related fields (e.g., Regulated Industries, Policy Analysis) are a plus.
  </li>
 </ul>
 <p>
  <strong>
   Experience
  </strong>
 </p>
 <ul>
  <li>
   3&ndash;5+ years in regulatory affairs, policy analysis, or compliance within the renewable energy/power sector (solar, wind, BESS or hybrids).
  </li>
 </ul>
 <p>
  <strong>
   Technical Expertise
  </strong>
 </p>
 <ul>
  <li>
   Strong research, drafting, and analytical capabilities.
  </li>
  <li>
   Proficiency in MS Office (Word, Excel, PowerPoint); experience with data analysis tools is a plus.
  </li>
 </ul>
 <p>
  <strong>
   Preferred Attributes
  </strong>
 </p>
 <ul>
  <li>
   Solid understanding of electricity laws, renewable energy policies, open access, and transmission regulations.
  </li>
  <li>
   Excellent written and verbal communication skills; ability to interact with clients, internal teams, and authorities.
  </li>
  <li>
   Prior experience in renewable energy project development and regulatory submissions.
  </li>
  <li>
   Strong stakeholder management and relationship-building skills.
  </li>
  <li>
   Leadership capability and team coordination experience.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Additional Information
  </strong>
 </p>
 <p>
  <strong>
   We Offer
  </strong>
 </p>
 <ul>
  <li>
   An international, collaborative work environment with diverse colleagues.
  </li>
  <li>
   Open, inclusive culture supporting professional and personal growth.
  </li>
  <li>
   Challenging and impactful assignments across projects.
  </li>
  <li>
   Competitive remuneration aligned with experience.
  </li>
  <li>
   Opportunities for career advancement within a growing organization.
  </li>
 </ul>
 <p>
  <strong>
   Equal Opportunity &amp; Accessibility
  </strong>
 </p>
 <ul>
  <li>
   Solarian Astra Pvt. Ltd. is an equal opportunity employer. We value diversity and are committed to an accessible recruitment process and accommodations as needed to support applicants with disabilities.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   How to Apply
  </strong>
 </p>
 <p>
  Please send your resume and a cover letter outlining your regulatory experience and fit for this role to [admin@solarianastra.com] with the subject line &ldquo;Manager &ndash; Regulatory Affairs Application.&rdquo;
 </p>
</div>


Senior Manager Regulatory Affairs

Gates Foundation

<div><div>The Foundation</div><div>
We are the largest nonprofit fighting poverty, disease, and inequity around the world. Founded on a simple premise: people everywhere, regardless of identity or circumstances, should have the chance to live healthy, productive lives. We believe our employees should reflect the rich diversity of the global populations we aim to serve. We provide an exceptional benefits package to employees and their families which include comprehensive medical, dental, and vision coverage with no premiums, generous paid time off, paid family leave, foundation-paid retirement contribution, regional holidays, and opportunities to engage in several employee communities. As a workplace, we&rsquo;re committed to creating an environment for you to thrive both personally and professionally.</div><div></div><div>
The Team</div>
The Global Health Division seeks to harness advances and innovations in science and technology to save lives in developing countries. We work with partners to deliver proven tools and diagnostics, as well as discover pathbreaking new solutions that are affordable and reliable.<br>
<br>
Integrated Development (IDEV) is a cross functional team within the Global Health Division but also supports teams in Global Development and Gender Equality Divisions at the Gates Foundation. IDEV brings expertise in service to R&amp;D and systems development in the four domains of Regulatory, Chemistry Manufacturing and Controls (CMC), Quantitative Sciences including pharmacology and big data, and Clinical Trials design and informativeness (DAC).<br>
<br>
Within the regulatory domain sit several subdomains or Bodies of Work (BOW). Several of these bodies of work focus on strengthening regulatory systems. One such BOW focuses on global initiatives to strengthen regulatory systems. Our major partner within this BOW is the World Health Organization. Another BOW is one that focuses of non-Africa based regulatory systems strengthening initiatives, many of which involve partnerships with academic institutions, high income country regulatory authorities, and others to support our regulatory systems strengthening work in Africa, and that focus on initiatives in non-African geographies. Another BOW focuses exclusively on strengthening African regulatory systems throughout the African continental, regional, and national regulatory ecosystem. The vision of this BOW is: &ldquo;All of Africa has access to quality essential medical products through strong Africa regulatory systems anchored on ML3/ML4/WLA agencies, RECs, AMA, reliance and innovation.&rdquo; The Africa Regulatory Systems Body of work (BOW), a partnership with the Africa Regional Office, was established at end of 2021.<div></div><div>
Your Role</div><div>
As a Senior Program Officer, Regulatory Affairs, you will report to the Deputy Director, Regulatory, Integrated Development and should be able to work remotely in the United Kingdom or Belgium. You are creative, thoughtful, and a curious leader that identifies as a problem solver, trusted business partner, and subject matter expert in regulatory affairs, especially European regulatory affairs and international regulatory systems.</div><div></div><div>
You would be responsible for managing and developing a portfolio of grants focusing on optimizing regulatory systems through which medical products (medicines, vaccines, and <i>in vitro</i> diagnostics) and vector control products must go to be and stay safely marketed and procured legally in Foundation focus countries (primarily low-income countries in sub-Saharan Africa). The role and responsibilities of the Senior Officer will be focused on two separate but related general portfolios of work:</div><div></div><div>
Working with the foundation&rsquo;s Africa regulatory systems Deputy Director, support the establishment of an agile, efficient, and impactful African Medicines Agency (AMA) through thought-partnership with and advice to the AMA Secretariat; facilitate the AMA&rsquo;s exchange and experience sharing with the European Medicines Agency senior leadership, technical committees and working groups; and support the development, execution, and tracking of the Foundation&rsquo;s AMA support strategy. Working with the foundation&rsquo;s Global regulatory systems Deputy Director, support the foundation&rsquo;s significant partnership with the WHO and its regional offices, and the foundation&rsquo;s partnerships with other non-Africa based institutions, including the EMA and other European regulatory authorities; facilitate the development and implementation of grants and strategies with the WHO&rsquo;s divisions and departments involved with prequalification of medical products and with regulatory systems strengthening work within WHO member states, including meeting with and supporting WHO leaders in these areas up to the level of the Assistant Director General; support the development, execution, and tracking of the Foundations global regulatory systems strategies.</div><div></div><ul><li><i>This position is a limited-term position for 2-Years</i></li></ul><div></div><div>
What You&rsquo;ll Do</div><ul><li>
Manage, develop, and help drive a portfolio of high-impact, complex grants and contracts requiring project development and management skills, as well as high-level strategy and interpersonal skills. Responsibilities include:<div>
Manage a complex network of implementing partners / grantees, for example by conducting site visits, providing technical guidance, convening meetings of key stakeholders, and applying and evaluating performance objectives.</div><div>
Review letters of inquiry and grant proposals; provide recommendations for funding including drafting and editing proposal summaries for submission to the Deputy Director, Director, President, Chief Executive Officer, and Chair.</div><div>
Partner with grantees to develop projects and define key outcomes and milestones. Ensure appropriate monitoring and evaluation systems and processes are established to produce robust evaluation of performance against milestones and outcomes.</div><div>
Collaborate with program and functional team members to manage internal processes, portfolio progress, documentation, and grant budget information and reporting.</div><div>
Serve as a point of contact on portfolio-related issues for key internal and external stakeholders.</div></li><li>
Represent the foundation to key program-related external constituencies and, as appropriate, on committees related to area of expertise and responsibilities of the position. This could include both formal and informal presentations such as making speeches, attending conferences and other meetings, as necessary.</li><li>
Write and produce informative briefings and other materials on role relevant key issues for Global Health team members and foundation leadership.</li><li>
This role is responsible for high quality interactions and clear and consistent communications with grantees and partners in the field.</li><li>
Travel will be predominantly in Europe, Africa, and the United States, and in other locations, as needed. Ability to travel around 35% expected.</li><li>
Work within a team of equally dedicated and senior regulatory experts responsible for the various regulatory bodies of work who are in the US and Africa.</li></ul><div></div><div>
Your Experience</div><ul><li>
Advanced degree required with demonstrated experience or equivalent.<ul><li>
MD, PhD, or LLM/JD (or equivalent)&ndash; with significant expertise after degree preferred</li><li>
Deep expertise in Regulatory Affairs or in a national/regional medical products Regulatory Agency involving vaccines, biologics, drugs, and/or devices/diagnostics. Experience working within the EMA and the European regulatory system preferred; experience working within WHO or a WHO-related institution preferred; experience with both highly preferred.</li><li>
French language conversational competency, in addition to English, preferred.</li></ul></li><li>
Can communicate intricate regulatory and science concepts and nuances to partners with a diverse set of backgrounds, including senior leadership, program staff, grantees, and other foundation operational resources.</li><li>
Experience developing and implementing regulatory projects in Europe and Africa strongly preferred.</li><li>
Demonstrated excellent project leadership, analytical, interpersonal, and written and oral communication skills, in positions requiring communication of data and results with a diverse audience of international stakeholders.</li><li>
Experience in pharmaceutical regulatory affairs (preferably in a regulatory agency), from research and clinical development to post-authorization and life-cycle management (including marketing authorizations) for vaccines, medicines, diagnostics, and/or vector control products, preferred.</li><li>
Demonstrated record of accomplishment of working collaboratively in a team-oriented, highly demanding environment with strong organizational and communications skills, at multiple levels of an organization. Self-motivated and self-managing.</li><li>
Experience in the conception, design and management of strategies, initiatives and programs including experience in managing complex projects and processes, from workplan development to implementation.</li></ul><div></div><div>
Other Attributes</div><ul><li>
Strong problem solving and strategy development experience.</li><li>
Project management skills, organization skills, and relationship management skills necessary to work daily with the regulatory experts in any of our partner systems to help them implement.</li><li>
Demonstrated ability to work flexibly and effectively within a geographically dispersed and time-zone diverse team.</li></ul><div></div><div>
The salary range for this role is $186,400 to $288,800. We recognize high-wage market differences in Seattle and Washington D.C., where our offices are located. The range for this role in these locations is $203,100 to $314,900 USD. As a mission-driven organization, we strive to balance competitive pay with our mission. New hires salaries are typically between the range minimum and the salary range midpoint. Actual placement in the range will depend on a candidate&rsquo;s job-related skills, experience, and expertise, as evaluated during the interview process.</div><div></div><div><br>
Hiring Requirements</div><div>
As part of our standard hiring process for new employees, employment will be contingent upon successful completion of a background check.</div><div></div><div>
Candidate Accommodations</div><div>
If you require assistance due to a disability in the application or recruitment process</div><div></div><div>
Inclusion Statement</div><div>
We are dedicated to the belief that all lives have equal value. We strive for a global and cultural workplace that supports ever greater diversity, equity, and inclusion &mdash; of voices, ideas, and approaches &mdash; and we support this diversity through all our employment practices.</div><div></div><div>
All applicants and employees who are drawn to serve our mission will enjoy equality of opportunity and fair treatment without regard to race, color, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender expression, national origin, genetic information, veteran status, marital status, and prior protected activity.</div></div>

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