Regulatory Affairs CMC Manager job in Leeds, England

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Contract

Discipline: Senior/Director & VP, CMC, RA Intelligence

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

Regulatory Affairs CMC Manager - Remote - Contract

Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position.

Primary Responsibilities:

This role involves working closely with regulatory CMC and cross-functional teams to ensure the successful execution of commercial filing plans.

Skills & Requirements:

Knowledge of regulations and guidelines governing the development, licensure, and marketing of chemical drugs, biologics, or gene therapies.
Strong project management skills.
Excellent communication and collaboration skills.
Ability to identify issues and develop risk mitigation strategies.

The Regulatory Affairs CMC Manager will:

Represent regulatory CMC at relevant site meetings and provide timely and accurate feedback to support site initiatives.
Manage the compilation of all necessary documentation for commercial regulatory CMC submissions and responses to questions, ensuring high quality and compliance with regulations and guidelines.
Collaborate with U.S. and UK teams to prepare change controls and GMP documentation to support global submissions for product registrations and/or renewals.
Participate in cross-functional project teams as a regulatory CMC representative, ensuring consistent communication within the department and with other functional areas.
Proactively identify issues and suggest appropriate strategies to mitigate risks.
Assist in the preparation for interactions with global regulatory authorities.

If you are having difficulty in applying or if you have any questions, please contact Caitlin Siljeur at C.Siljeur@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.