Consultant - Commercial Content (Remote)

4 weeks ago


Leeds, United Kingdom Proclinical Group Full time

Senior Regulatory Consultant - Remote - Contract
Proclinical is actively seeking a Senior Regulatory Consultant. This is a remote contract position.
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. 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
Familiarity with regulatory submissions for biotech products
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
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.


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