Regulatory Expertise Senior Manager
4 dagen geleden
Scendea is a leading international product development and regulatory consulting group. Our team of experts delivers market-leading scientific expertise & regulatory solutions to advance healthcare innovation worldwide.
About the RoleWe are seeking a highly motivated individual to join our global team as a full-time Principal Consultant (CMC). This hybrid position is affiliated with our Breda, Netherlands office, requiring a minimum of one day per month in the office.
Key Responsibilities- Provide strategic, technical, and regulatory advice/services to clients with a special interest in CMC development of human medicinal products.
- Develop innovative drug development plans, data gap analyses, and international regulatory strategies from a CMC perspective for complex products within the changing regulatory environment.
- Contribute to technical authorship and review of development regulatory documents, including Regulatory Strategy Plans, Drug Development Plans, Clinical Trial Applications, and more.
- Lead multi-jurisdiction programs of work and deliver consulting services within your respective area of expertise.
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