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Director of Regulatory Affairs
2 months ago
Director of Regulatory Affairs
Our client, a global pharmaceutical company is seeking a Director of CMC Operations to lead and grow its CMC capabilities in Europe. This role will be pivotal in shaping early-stage drug development strategy, working across a diverse portfolio including small molecules, peptides, and macromolecules.
About the Role:
You will be responsible for expanding the company’s CMC operations in Europe, collaborating closely with North American counterparts to establish a unified framework across regions. The role requires a seasoned expert who can lead early-stage development, regulatory submissions, and product market approvals. You’ll be the go-to CMC specialist in Europe and serve as a regulatory partner to the team, working with both contingent support and the potential for future team expansion based on workload demands.
Key Responsibilities:
- CMC Leadership: Oversee and expand the European CMC function, aligning it with global initiatives and strategy.
- Early-Stage Development: Manage activities related to full drug development and a focus on bringing new products to market.
- Technical Expertise: Leverage a deep understanding of small molecules, peptides, and macromolecules, as well as varied delivery technologies (e.g., injectors).
- Regulatory Collaboration: Act as a regulatory partner to European teams, coordinating with cross-functional teams to ensure alignment.
- Cross-Regional Coordination: Work closely with North American teams, understanding and integrating CMC operations across regions.
Ideal Candidate Profile:
- Experience: 10+ years in CMC, preferably with experience in branded pharma or biotech environments. The ideal candidate has expertise in early-stage work with market approvals and hands-on involvement in product development.
- Technical Breadth: Exposure to a variety of dosage forms and delivery methods, beyond a single therapy area.
- Scientific Foundation: Grounded in the science of CMC, with a background in drug production and development.
- Autonomy and Leadership: Able to work independently, demonstrating the ability to lead and grow the CMC function in Europe.
- Global Mindset: Comfortable working within a global framework, with strong communication skills to coordinate across regions and occasional early or late calls.
Additional Information:
- This position is based in Europe, with occasional travel to the office.
- Initial support will include contingent workers, with the possibility of expanding the team as workload demands increase.
- Candidates should be ready to start as soon as possible, with a significant increase in workload anticipated in the new year.
