Regulatory Affairs Manager - CMC

Parkside; Cambridge; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading biopharma company seeks a Regulatory Affairs Manager (CMC) for a 12-month contract in Cambridge. The role involves preparing regulatory submissions, managing CMC documentation, and ensuring compliance with international regulatory requirements. Ideal candidates will have significant experience in regulatory affairs and strong communication skills.

Qualifications

• Significant experience in regulatory affairs.
• Extensive knowledge of regulatory requirements.
• Competence in managing regulatory documentation.

Responsibilities

• Coordinate the preparation of CMC documents for regulatory submissions.
• Work with various teams to deliver CMC components.
• Maintain awareness of CMC regulatory requirements.

Skills

Regulatory Affairs Experience

Knowledge of ICH Requirements

Regulatory Documentation Management

Communication Skills

Organizational Skills

Job description

Regulatory Affairs Manager - CMC, Cambridge

Client:

Location:

Cambridge, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

Job Reference:

936d81610483

Job Views:

4

Posted:

25.06.2025

Expiry Date:

09.08.2025

Job Description:

My client is a global biopharma company. They are seeking a Regulatory Affairs Manager (CMC) to join our Regulatory Affairs Team based in Cambridge on a 12 month contract.

Key Responsibilities

• Co-ordinate the preparation of high quality CMC documents to support regulatory submissions in International regions, (Asia, Latin America, Middle East, Eastern Europe and Africa)
• Work with pharmaceutical development, manufacturing, QA and external partners to deliver the CMC components for marketing applications, variations and renewals
• Co-ordinate the preparation of responses to CMC questions from regulatory authorities
• Maintain an up-to-date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the organization in a timely manner

Knowledge, Experience and Skills

• Must have significant experience in regulatory affairs and an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements
• Must be capable of the preparation and finalization of CMC regulatory dossiers and managing the ongoing maintenance of existing product licenses
• Well versed and competent with regulatory documentation and submission management systems
• Excellent verbal, written and interpersonal communication skills are required
• Must have excellent organizational skills and an ability to work on a number of projects with tight timelines.

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Created on 25/06/2025 by TN United Kingdom