Regulatory CMC Lead

Help bring science to life and join a leading pharmaceutical company where you can play a key role within Regulatory Affairs and assist in driving healthcare innovation!

This position will ensure compliance with regional and global regulatory requirements for established products. You will develop and implement regulatory strategies, lead interactions with regulatory agencies, and manage a regulatory team. This role focuses on maintaining compliance and addressing regulatory changes in global markets.

Responsibilities:

• Develop and implement regional and global regulatory strategies for established products.
• Lead and manage interactions with regulatory authorities.
• Collaborate with commercial, MSAT, CMC, Supply Chain, Medical Affairs, and Pharmacovigilance teams.
• Ensure compliance with internal processes and external regional regulatory requirements.
• Monitor and address regulatory changes in global markets and share knowledge.
• Lead and coach regulatory professionals, providing feedback and defining clear objectives aligned with company goals.
• Make responsible decisions to drive team performance.

Key Skills and Requirements:

• Advanced degree in life sciences.
• In-depth knowledge of European, UK, and ROW regulatory environments, particularly CMC requirements.
• Expertise in developing and maintaining medicine registrations in EU and UK.
• Significant experience managing lifecycle regulatory activities for established products.
• Expert knowledge of regulatory affairs in infectious disease and internal medicines.
• Sound knowledge of quality and clinical guidelines in EU and the UK.
• Hands-on experience leading technology and marketing authorization transfers in EU.
• Proven experience with EU regulatory procedures, especially MRP/DCP/CP and NP.
• Effective collaboration within CMC teams and matrix environments.
  

If you are having difficulty in applying or if you have any questions, please contactJosh Thompsonat.

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