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: Masters 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.