Overview In this role you help shape global regulatory strategies for VID vaccines and infectious disease products. You will collaborate with a global liaison and cross-functional teams to develop and implement submissions and lifecycle plans. You'll research guidelines, prepare regulatory documents, and support agency interactions to advance marketing applications and updates. This position offers the chance to influence regulatory strategy, with a focus on global alignment and lifecycle management within a leading pharma environment.
Compensation / Benefits- medical, dental, vision insurance
- retirement benefits including 401(k)
- paid holidays and vacation
- compassionate and sick days
- annual bonus and long-term incentive
- hybrid work arrangements
Responsibilities- Assist regulatory agency communications and submissions (INDs, marketing applications, pediatric plans, periodic reports)
- Track, author, shepherd, and review responses to Agency requests
- Develop agency background packages and submission documents for marketing applications
- Engage with agencies and participate in agency meetings to support the Global Liaison
- Contribute to cross-functional meetings and regulatory strategy discussions
- Research guidelines, regulatory precedence, and competitive intelligence to inform strategy
- Co-author regulatory strategy documents with the Global Liaison
- Coordinate regulatory strategy across Regulatory Operations, Clinical Safety, Labeling, CMC, and other functions
- Support maintenance and lifecycle management of VID programs
- Assist with label development and process improvement initiatives
- Perform regulatory administrative activities as needed
Key requirements- M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline, or Master's with 3+ years of relevant pharma experience, or Bachelor's with 6+ years of relevant pharma experience
- Excellent communication skills (oral and written)
- Strong organizational skills and ability to manage multiple projects
- Flexibility and adaptability
- Strong scientific and analytical abilities with attention to detail
- Preferred: prior regulatory experience and experience in drug development, particularly anti-infectives and/or vaccines
- Excellent communication
- Strong organizational skills
- Flexibility
- Regulatory strategy development
- Regulatory submissions and documentation
- Lifecycle planning and maintenance
