Regulatory & Scientific Affairs Manager

Job Purpose:

To lead and coordinate the preparation, review, and submission of responses to deficiency letters raised by the UK/EU regulatory agencies during the evaluation of Marketing Authorisation Applications (MAAs). The role ensures high-quality, scientifically sound, and compliant responses in line with regulatory expectations and timelines.

Key Responsibilities:

1. Query Response Coordination

- Lead the end-to-end process of query management for new applications
- Review deficiency letters, assess the nature and scope of questions, and develop clear action plans with internal and external stakeholders.
- Coordinate with cross-functional teams (Development, Clinical, Nonclinical, Pharmacovigilance, Quality, Manufacturing, etc.) to obtain required information and justifications.
- Consolidate and critically review all data and documents to ensure consistency, accuracy, and regulatory compliance prior to submission.

2. Regulatory Writing and Review

- Draft and review scientifically sound responses addressing concerns on quality, safety, and efficacy aspects.
- Ensure alignment with regulatory guidelines (MHRA guidance, EU guidance, ICH guidelines, etc.).
- Maintain consistency across the dossier.

3. Communication and Liaison

- Serve as the primary point of contact with agencies for clarification and follow-up on queries.
- Coordinate with consultants, partners, development site and contract manufacturing/testing sites for timely data retrieval.

4. Quality and Compliance

- Ensure all responses meet formatting and procedural requirements (e.g., eCTD structure, proper referencing etc).
- Adhere to internal quality systems, SOPs, and regulatory documentation control procedures.
- Track and monitor timelines to ensure all submissions meet regulatory deadlines.

5. Continuous Improvement and Knowledge Management

- Stay updated with regulatory trends, procedural updates, and assessment practices.
- Train and mentor junior regulatory team members on query response strategies and best practices.
- Support in developing templates, SOPs, and checklists for query management and response preparation.

Qualifications and

Experience:

- Education:

Master’s degree in Pharmacy

Experience:

- Minimum 8 years of experience in Regulatory Affairs, preferably UK and EU regions.
- Strong understanding of CTD/eCTD structure, ICH, and EU/UK regulatory frameworks.