
Principal Consultant
3 days ago
Regulatory Leadership Opportunity
About the Role- Pursue strategic regulatory approaches for complex products.
- Mentor and grow a high-performing team of professionals.
This seasoned CMC and Regulatory Affairs Principal Consultant will shape the regulatory strategy of clients' intricate products. Collaborating closely with cross-functional teams, you'll author and review impactful regulatory documents and represent clients in meetings with regulatory agencies.
Key Responsibilities- Develop innovative product strategies for biologics, vaccines, and cutting-edge therapies.
- Navigate FDA, EMA, and ICH guidelines to ensure compliance.
- Create and review crucial regulatory documentation.
- Represent clients effectively in agency meetings.
- Lead successful international programs.
Requirements
- At least 10 years of experience in regulatory submissions and interactions with agencies.
- Demonstrated expertise in CMC development and regulatory affairs.
- A strong background in consultancy, strategic planning, and leadership.
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