Sr. Manager, Regulatory Affairs

Vor 7 Tagen

Basel, Schweiz Moderna Vollzeit

**The Role**:
**Here's What You’ll Do**:

- Develop and contribute to content, format and accountability for regulatory submissions and related supplements and amendments, including National Scientific Advice (NSA) meeting requests, briefing books, orphan drug designations, MAA etc.)
- Work with the Director-RA International, Reg-CMC, and Global Regulatory Sub-Teams regarding the development and execution of regulatory strategy in Switzerland
- Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs
- Identify and assess regulatory risks for assigned projects or programs
- Interact with Swissmedic 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 regulations
- 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
- 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
- A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative

**About Moderna**
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most effective vaccines against the COVID-19 pandemic.
- Moderna is a smoke-free, alcohol-free and drug-free work environment._

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