Associate Principal Scientist supporting regulatory strategies for Vaccine & Infectious Disease products. Collaborating globally and assisting submissions for regulatory compliance in the pharmaceutical industry.
About the role
- Principal Scientist/Director responsible for regulatory strategies for biologics products. Overseeing CMC regulatory submissions and leading cross-functional teams in compliance and submission accuracy.
Responsibilities
- Responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies
- Leading the preparation and submission of CMC sections for commercial or new biologics products
- Provide CMC Regulatory leadership within Regulatory and on cross-functional teams
- Develop and execute detailed global regulatory submissions
- Collaborate with partner groups to ensure compliance, scientific excellence, accuracy, and completeness of submissions
- Resolve complex project issues through collaboration and provide recommendations to Regulatory CMC leadership team as appropriate.
Requirements
- B.S. in a biological science, engineering, or a related field (advanced degree preferred)
- At least ten years of relevant experience including biologics or vaccine Regulatory CMC, or development; manufacturing, testing, or licensure of biological products; or closely related fields.
- Strong listening skills.
- The candidate must be proficient in English; additional language skills are a plus.
- The candidate may be required to travel on a periodic basis.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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