Senior Regulatory Consultant job in Leeds, England

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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*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Contract

Discipline: Consultant / Specialist, CMC

Location: United Kingdom

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

Senior Regulatory Consultant - Remote - Contract

Proclinical is actively seeking a Senior Regulatory Consultant. This is a remote contract position.

Primary Responsibilities:

This role primarily involves providing regulatory CMC support for post-approval submissions for commercial products, with a focus on biotechnology products. The successful candidate will also be involved in new international MAA filings, predominantly in the EMEA region. This position reports to the Executive Director.

Skills & Requirements:

Proficiency in generating global regulatory strategy documents
Proven leadership skills, with experience leading a team of authors to generate regulatory content
Strong knowledge of regulatory legislation and CMC guidance in EU, US, and ICH markets
Experience with international MAA and post-approval filings
Familiarity with regulatory submissions for biotech products
Experience with Agency interaction is preferred

The Senior Regulatory Consultant will:

Provide regulatory CMC support for post-approval submissions for commercial products
Lead a team of SME authors to generate variation/supplement content for regulatory approvals
Develop global regulatory strategy documents
Participate in international MAA and post-approval filings

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@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.

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