Intl. CMC R/A Director

Proclinical is on the lookout for a dynamic and collaborative individual to fill the role of Intl. CMC R/A Director. This role involves providing operational, tactical, and strategic International CMC RA expertise and direction for CMC submissions across the lifecycle of a product. The successful candidate will also contribute to policy setting and strategy development in the International CMC RA environment.

Responsibilities:

• Provide International CMC RA expertise across business functions and lead key business improvement initiatives.
• Lead CMC related interactions with Health Authorities for the international markets.
• Deliver the CMC Regulatory Submissions in support of new products and lifecycle management.
• Contribute to policy setting and strategy development in the International CMC RA environment.
• Lead knowledge sharing and provide coaching within CMC RA and wider business functions.
• Manage high level risk by making complex judgments and developing innovative solutions.
• Support the implementation of agile and novel approaches in CMC Dossier Management.
• Participate and/or lead due diligence teams as necessary.
• Provide regulatory leadership in product in-license/due diligence review, product divestment, and product withdrawal.

Key Skills and Requirements:

• Degree/PhD or equivalent professional qualification in a science or technical field such as pharmacy, biology, chemistry, or biological science.
• Broad knowledge of manufacturing, project, technical, and regulatory project management.
• Strong understanding of regulatory affairs globally.
• Direct Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products.
• Stakeholder & Project management skills.
• Professional capabilities: Regulatory knowledge.

If you are having difficulty in applying or if you have any questions, please contact Jaeme Pawl at j.pawl@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.