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 PharmacyExperience:- 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.

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