
Product Development Regulatory Affairs Specialist
5 days ago
Regulatory Affairs Expertise Drives Global Product Development
We are seeking an experienced Regulatory Affairs Principal Consultant to drive strategic development of complex products in the global market.
This role offers the opportunity to lead cross-border programs, author high-impact regulatory documents and represent clients in agency meetings.
- Developing product strategies for biologics, vaccines and advanced therapies
- Navigating FDA, EMA and ICH guidelines
- Leading cross-border programs and representing clients in agency meetings
The ideal candidate will have deep expertise in CMC development and regulatory affairs, backed by a minimum of ten years of experience in regulatory submissions and agency interactions. A strong background in consultancy, strategic planning and team leadership is essential for success.
About This Opportunity:
We offer a dynamic and collaborative environment where you can leverage your expertise to drive business growth.
Requirements:
- Minimum 10 years' experience in regulatory affairs and submissions
- Deep expertise in CMC development
- Strong knowledge of FDA, EMA and ICH guidelines
- Excellent communication and project management skills
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