Regulatory Consultant – CMC, Small Molecule Products

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Assist in the implementation of global regulatory CMC for marketed small molecule products across multiple product lines.

• Aid in the drafting and submission of regulatory CMC documentation.

• Offer regulatory assistance to various cross-functional teams.

• Implement the commercial Lifecycle Management (LCM) strategy and submissions, particularly targeting the Middle East and North Africa.

• Evaluate CMC sections of regulatory submissions and manage interactions with regulatory agencies concerning small molecule products.

• Collaborate with regulatory colleagues to develop global regulatory CMC strategies and submissions.

• Actively participate in cross-functional teams and may function as the primary regulatory CMC liaison for assigned products and projects.

⛳️ Requirements

• Assist in the implementation of global regulatory CMC for marketed small molecule products across multiple product lines.

• Contribute to the drafting and submission of regulatory CMC documentation.

• Provide regulatory assistance to various cross-functional teams.

• Implement the commercial Lifecycle Management (LCM) strategy and submissions, with a focus on the Middle East and North Africa.

• Assess CMC sections of regulatory submissions and manage interactions and responses with regulatory agencies for small molecule products.

• Collaborate with regulatory colleagues in the development of global regulatory CMC strategies and submissions.

🏝️ Benefits

• We are dedicated to nurturing our employees through career development and advancement opportunities, supportive and engaged management, technical and therapeutic area training, peer recognition, and a comprehensive total rewards program.

• We are committed to fostering an inclusive culture where you can truly be yourself.