At a Glance
- Tasks: Lead regulatory activities and develop CMC strategies for groundbreaking mRNA medicines.
- Company: Join Moderna, a pioneering company revolutionising medicine with mRNA technology.
- Benefits: Best-in-class healthcare, generous paid time off, and holistic well-being support.
- Other info: Dynamic role with opportunities for career growth and international collaboration.
- Why this job: Make a significant impact on global health while working with cutting-edge biotechnology.
- Qualifications: 10+ years in pharma/biotech, strong knowledge of EU regulations, and exceptional communication skills.
The predicted salary is between 80000 - 100000 £ per year.
The Role
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.
Moderna is expanding its international presence, integrating cutting‑edge biotechnology within the vibrant hub of pharmaceutical innovation. We invite professionals to join us in Basel, contributing to our mission of delivering groundbreaking mRNA medicines and impacting lives worldwide.
Moderna is seeking an experienced Associate Director for Global Regulatory Science, CMC. This pivotal role involves leading regulatory activities, developing CMC strategies for international submissions, ensuring compliance, and guiding product development projects. You will be at the forefront of preparing and overseeing critical regulatory documentation, directly contributing to the development of transformative medicines for patients.
Key Responsibilities
- Within 3 months, develop and implement effective CMC regulatory strategies for international submissions.
- Within 3 months, start reviewing documents for submission‑readiness, ensuring conformity with health authority guidelines.
- Within 3 months, begin providing regulatory guidance to manufacturing and quality teams.
- Within 6 months, lead regulatory CMC discussions and interactions with health authorities.
- Within 6 months, enhance regulatory processes and procedures supporting CMC components.
- Within 6 months, support the creation and maintenance of CMC submission templates.
- Within 12 months, provide comprehensive CMC regulatory guidance for various therapeutic areas.
- Within 12 months, oversee multiple programs, evaluating CMC change controls and their impact on internal programs.
- Within 12 months, lead and support all regulatory activities, delivering high‑quality CMC sections of regulatory documentation.
Basic Qualifications
- BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
- MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable.
- 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus.
- 8+ years of experience in Biologics focused Regulatory CMC.
- Multidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases).
- Strong knowledge of current EU and ROW regulations.
- Strong knowledge of Cgmp.
- Strong experience with CTD format and content regulatory filings.
- Exceptional written and oral communication.
- As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre‑employment check.
Pay & Benefits
- Best‑in‑class healthcare, plus voluntary benefit programs to support your unique needs.
- A holistic approach to well‑being with access to fitness, mindfulness, and mental health support.
- Family building benefits, including fertility, adoption, and surrogacy support.
- Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown.
- Savings and investments to help you plan for the future.
- Location‑specific perks and extras.
Equal Opportunity & Accommodation Statement
Moderna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com.
