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.