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:
1. Proficiency in generating global regulatory strategy documents
2. Proven leadership skills, with experience leading a team of authors to generate regulatory content
3. Strong knowledge of regulatory legislation and CMC guidance in EU, US, and ICH markets
4. Experience with international MAA and post-approval filings
5. Familiarity with regulatory submissions for biotech products
6. Experience with Agency interaction is preferred
The Senior Regulatory Consultant will:
7. Provide regulatory CMC support for post-approval submissions for commercial products
8. Lead a team of SME authors to generate variation/supplement content for regulatory approvals
9. Develop global regulatory strategy documents
10. Participate in international MAA and post-approval filings