
Strategic Product Development Specialist
2 weeks ago
Regulatory Affairs Expert Sought
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.
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.
Key responsibilities include:
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
Apply today and join a dynamic and collaborative environment where you can leverage your expertise to drive business growth.
Key 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
What We Offer
Opportunity to shape regulatory strategy for complex products
Chance to mentor and develop a high-performing team
Collaborative work environment with a dynamic team
Seniority Level
: Mid-Senior level
Employment Type
: Full-time
Job Function
: Science
Industries
: Business Consulting and Services
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