Privacy Engineer, VP
State Street
Cyber Security
VP, Chemistry, Manufacturing and Controls – CMC
Allucent
contract
Posted on:
Location: 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Lead Regulatory Writing & Strategy: Write, review, and guide CMC documents and submissions with accuracy and insight.
- Shape Product Development: Influence strategies and plans from early development through post-approval.
- Engage with Health Authorities: Lead meetings, prepare briefing packages, and serve as the expert voice in regulatory interactions.
- Provide Scientific Leadership: Share expertise in CMC, compliance, and audits while mentoring teams and supporting client success.
- Drive Collaboration & Solutions: Partner with clients and cross-functional teams to solve challenges and deliver innovative outcomes.
Requirements
- Advanced scientific and regulatory knowledge of drug, biologic, or device development
- Critical thinking and analytical skills, financial acumen, influencing and leading teams, risk assessment, problem solving skills, decision making, strong written and verbal communication skills in English
- Requires a B.S., R.Ph., M.S., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
- 15 years’ post-degree of directly relevant experience in drug, biologic, or device development desirable
