Senior Regulatory Consultant

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.