Associate Principal Scientist, Regulatory Liaison
$142.4k - $224.1kMerck
Associate Principal Scientist supporting vaccine and infectious disease products within a regulatory affairs team. The role involves developing global regulatory strategies, preparing submissions, and collaborating across functional teams to ensure product registration and compliance.
Responsibilities
- Assist in preparing and submitting regulatory applications, INDs, and periodic reports to agencies
- Develop agency background packages and documents for marketing applications
- Conduct research on regulatory guidelines, precedents, and competitive intelligence
- Participate in cross-functional meetings and collaborate on global regulatory strategy
- Support label development and lifecycle management of vaccine and infectious disease programs
Requirements
- M.D., Ph.D., or related doctoral degree in biological science or chemistry
- Master's degree with 3+ years pharmaceutical industry experience, or Bachelor's with 6+ years experience
- Excellent oral and written communication skills
- Strong organizational and multitasking abilities with flexibility
- Scientific and analytical skills with attention to detail
- Prior regulatory experience preferred
- Experience in anti-infectives and/or vaccine development highly preferred
Compensation: $142,400–$224,100 base
Vacancy posted 13 days ago
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