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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