The Manager/Sr. Manager of Regulatory Affairs-International based in Basel, Switzerland will have the opportunity to provide regulatory support to the VP of RA-International and the General Manager of Moderna’s Swiss Affiliate. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges involved in supporting the Health Agency interactions in Switzerland for messenger RNA therapeutics as unprecedented new drug modality. The Manager/Sr. Manager will provide regulatory Clinical and CMC support across the Therapeutic Areas including Infectious Diseases. Their support includes but is not limited to managing the regulatory interactions and marketing authorization applications in Switzerland. This person will work closely with the business in Switzerland to provide the regulatory guidance to support the overall business plans including market access. Depending on the bandwidth, the Mgr/Sr. Manager may also be involved with other International regulatory interactions and submissions (orphan drug designations, pediatric plans, PRIME, DSURs, MAA, etc.)
Here's What You’ll Do:
Develop and contribute to content, format and accountability for regulatory submissions and related supplements and amendments, including Swiss regulatory documents such as meeting requests, briefing books, orphan drug designations, DSURs, MAA etc.)
Work with VP-RA International and Global Regulatory Sub-Teams regarding the development and execution of regulatory strategy in Switzerland and possibly the EU and International countries
Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs
Identify and assess regulatory risks for assigned projects or programs
Contact relevant regulatory agencies relevant to assigned projects or programs, as appropriate
Ability to work both independently and within project teams, committees, etc. to achieve group goals
Prepare and deliver effective communications and presentations for external and internal audiences
Here’s What You’ll Bring to the Table:
Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD)
5+ years of experience in the Pharmaceutical industry. 3+ years of experience in Regulatory strategy
Strong knowledge of current Swiss, EU and International regulations related to the clinical, nonclinical, and CMC development
Strong experience with CTD format and content regulatory filings
Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in the EU and International countries
Creates and maintains the Swiss-specific parts of regulatory dossiers including Information for Professionals and Patient and Packaging Information as well as National Succinct Statement.
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
Ability to work independently to manage multiple projects in a fast-paced environment
Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones
Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Project Teams and senior management, as relevant
Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned. Fluency in English and Swiss German is required.
A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science’s list of top biopharma industry employers for the past five years. To learn more, visit [...] Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Moderna is a smoke-free, alcohol-free and drug-free work environment.#LI-TR1