Interim Regulatory Affairs Consultant

Sector: Pharma

Current Salary Range: 650 per day

Location  Stevenage

About the Candidate

A Regulatory Affairs Professional with 30 years of Experience in Clinical and Chemistry, Manufacturing Controls (CMC). Expertise in Enterprise Regulatory Vault (ERV) Regulatory project management for marketed & development products registered over many emerging countries covering the following therapeutic areas: Cardiovascular, Anti-infectives, oncology and CNS products. Experience with current CTD/eCTD regulations and requirements.

What Makes them great?

Regulatory Strategy and Submissions Expertise: Proficient in preparing international regulatory submissions, including MAAs in emerging markets. Managed submissions for pharmaceutical products across multiple companies.

CMC Mastery: Extensive experience in CMC regulatory affairs, including Module 3 documentation, IMPDs, and variations. Specialized in managing post-approval activities and ensuring product compliance.

Project Management and Leadership: Led regulatory projects from planning to submission stages. Managed risks, maintained regulatory databases, and effectively communicated updates.

Their Experience

Regulatory Affairs

Other Details