Senior Manager, Global Regulatory Affairs - US Strategy
BioNTech
- Boston, MA Cambridge, MA
- Permanent
- Full-time
- Advise on US FDA procedures, requirements and administrative documentation
- Establish and maintain transparent and collaborative relationship with the Agency across all projects and for overarching non-project specific topics and initiatives
- Support the preparation and the review of regulatory documents and forms part of IND / BLA / NDA, expedited regulatory programs (BTD, PRIME, etc), and other regulatory filings to US FDA
- Secure timely submissions to FDA, in alignment with Global Regulatory Lead(s) (GRLs) and Regulatory Operations
- Plan and manage regulatory agency interactions, align with GRLs on communication strategy and coordinate correspondence with the Agency, proactively preparing the team and addressing any queries from the agency while facilitating effective communication practices
- Collaborate with Global Regulatory Leads on planning and implementation of the regulatory strategy for the assigned projects
- Establish and maintain proper regulatory processes for the regulatory handling and lifecycling of clinical trials, in alignment with Global Regulatory Operations and Clinical Research Organizations as appropriate, to ensure regulatory documentation is properly maintained according to internal SOPs, regulatory requirements and best practice
- University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent) or professional certification (e.g., RAC)
- Minimum 5 years professional working experience in Clinical Regulatory Affairs
- Extensive experience working with Health Authorities, and in particular with the US FDA, and submitting regulatory filings
- Basic knowledge of regulatory requirements and procedures in the EU/EEA and US throughout the product's life cycle
- Experience working with collaborators or external partners such as regulatory consultants, contract research organizations (CRO) and 3rd parties preferred
- Knowledge of multidisciplinary functions involved in clinical trials and pharmaceutical development
- Knowledge of clinical research and its application to drug development in therapeutic area of relevance such as Cancer and Infectious diseases
- Effective communicator with ability to negotiate with internal stakeholders and external partners
- Familiarity with eCTD and regulatory document management systems
- Thrives in a fast-paced environment with ability to manage multiple products and competing timelines