Overview You lead analytical strategy for a family of programs, ensuring readiness for regulatory filings and post-approval activities. You define specifications, control strategies, and comparability frameworks to enable licensure and lifecycle management. You collaborate across development, manufacturing, quality, and regulatory teams to deliver robust data packages and regulatory-ready narratives. Your role combines scientific rigor with regulatory excellence and program delivery. You will shape analytical approaches that support global submissions and ongoing lifecycle evolution.
Compensation / Benefits- competitive healthcare
- fitness, mindfulness, and mental health support
- family planning benefits
- generous paid time off and sabbatical options
- savings and investments
- location-specific perks
Responsibilities- Lead analytical program activities to support regulatory filings (IND, BLA/MAA) and lifecycle submissions
- Define integrated analytical strategies including specifications, control strategy, and comparability frameworks
- Establish commercial specifications and comparability for licensure and post-approval changes
- Ensure analytical readiness for clinical studies and commercial manufacturing (method qualification/validation, transfer, control strategy)
- Author/advise analytical sections of regulatory filings and responses to health authority questions
- Partner with QC, Regulatory CMC, MS&T, and Manufacturing to deliver compliant, inspection-ready data packages
- Identify and mitigate analytical risks with justification aligned to global expectations
- Mentor team members and drive consistent high-quality execution across programs
Key requirements- Experience in analytical development or quality control of biologics or vaccines
- Ability to translate analytical data into regulatory narratives
- Cross-functional collaboration skills with Regulatory, Quality, MS&T, and Manufacturing
- Strong written and verbal communication for regulatory submissions
- Ability to operate in a fast-paced, matrixed environment
- cross-functional collaboration
- regulatory-minded communication
- problem-solving
- analytical control strategy
- specification setting
- comparability strategy and study design
