CMC Regulatory Lead - Early-Stage Pharma (IMPs/IMPDs)

Gi Group (United Kingdom); Basel; On-site; CHF 110,000 - 170,000; Full time

Job summary

Gi Group is seeking a Regulatory Specialist (CMC) in Pharma Technical Regulatory (PTR) to lead global regulatory submissions and manage CMC information for IND, IMPD, and NDA/BLA/MAA filings. The role collaborates with affiliates, policy teams, and partners on early clinical stage programs and IMPD submissions.

The ideal candidate has 3–4 years of CMC regulatory experience, strong Veeva knowledge, and fluent English, with a track record in handling regulatory interactions and lifecycle

Qualifications

• Bachelor degree in a relevant field.
• 3-4 years of CMC regulatory and technical regulatory experience.
• Fluent in verbal and written English (C1).
• Solid knowledge of Veeva and Veeva Document Management for Regulatory submissions.
• Experience in CMC regulatory support for early clinical trials, IMPD preparation, and clinical regulatory submissions.
• Hands-on experience with Veeva Document Management for Regulatory submissions.
• Experience with Clinical Trial Applications for early to mid stage programs.

Responsibilities

• Global Submission Management: manage and execute global regulatory submissions for clinical and commercial products.
• CMC Lifecycle & Change Control: oversee end-to-end regulatory lifecycle management and maintain CMC docs in systems (Veeva).
• Cross-Functional Representation: act as PTR representative on cross-functional teams with global stakeholders.
• Regulatory Compliance & Strategy: ensure ongoing compliance and drive early approvals for CTAs and lifecycle extensions.
• Agency & Partner Interactions: communicate with regulatory authorities and external partners on technical matters.
• Operational Excellence: identify regulatory risks and drive process improvements for efficiency.
• Regulatory Intelligence: monitor global guidelines and assess impact on portfolios.

Skills

CMC regulatory experience

Regulatory submissions

English fluency

Education

Bachelor degree in a relevant field

Tools

Veeva

Veeva Document Management

Job description

Gi Group is seeking a Regulatory Specialist (CMC) in Pharma Technical Regulatory (PTR) to lead global regulatory submissions and manage CMC information for IND, IMPD, and NDA/BLA/MAA filings. The role collaborates with affiliates, policy teams, and partners on early clinical stage programs and IMPD submissions.

The ideal candidate has 3–4 years of CMC regulatory experience, strong Veeva knowledge, and fluent English, with a track record in handling regulatory interactions and lifecycle