Job Title: Regulatory Affairs Manager
Location: London, United Kingdom
We are a reputable pharmaceutical company dedicated to improving global healthcare and advancing life-saving treatments. Our commitment to innovation, quality, and compliance has earned us a leading position in the industry. As we continue to expand our product portfolio and reach new markets, we are seeking an experienced and driven Regulatory Affairs Manager to join our team in London.
As the Regulatory Affairs Manager, you will play a crucial role in ensuring the successful development and registration of pharmaceutical products in compliance with regulatory guidelines and requirements. Your primary responsibility will be to lead and coordinate regulatory affairs activities, working collaboratively with cross-functional teams, both internally and externally. The ideal candidate will possess a strong background in CMC (Chemistry, Manufacturing, and Controls) along with extensive experience in management, QA/QMS development, and a comprehensive understanding of global PV (Pharmacovigilance) strategies.
CMC Expertise: Provide strategic input and guidance on CMC aspects of drug development and regulatory submissions. Collaborate with R&D and manufacturing teams to ensure CMC compliance and high-quality submissions to health authorities.
Team Management: Lead and mentor a team of regulatory affairs professionals, fostering a collaborative and supportive work environment. Ensure the team’s success through performance management, training, and skill development.
Regulatory Roadmaps & Strategies: Develop and implement regulatory roadmaps and strategies for various products in the company’s portfolio. Proactively identify regulatory challenges and opportunities and recommend appropriate actions to maintain compliance and optimize product development.
PV/QA Due Diligence: Oversee the preparation and execution of regulatory due diligence activities related to PV and QA. Ensure that all compliance-related risks are identified, assessed, and appropriately managed.
Target Product Profiles (TPP): Develop and maintain TPPs in line with business goals and regulatory requirements. Collaborate with cross-functional teams to align product development strategies accordingly.
SME Designation: Act as the Subject Matter Expert (SME) in regulatory affairs, providing expert advice and guidance to internal stakeholders and external partners on complex regulatory matters.
Early FDA/EMA/UK Engagements: Lead early engagement activities with FDA, EMA, and UK regulatory authorities to obtain insights, guidance, and feedback on regulatory strategies and requirements.
Orphan & Pediatric Strategies: Develop and implement regulatory strategies for orphan drug and pediatric indications, ensuring compliance with relevant guidelines and regulations.
Qualifications and Experience:
Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
Minimum 5+ years of experience in regulatory affairs within the pharmaceutical industry.
Proven experience in CMC regulatory affairs and QA/QMS development.
Strong leadership and team management skills with a track record of successful project management.
Extensive knowledge of global PV strategies and pharmacovigilance regulations.
Previous experience in developing regulatory roadmaps and strategies for pharmaceutical products.
Familiarity with Target Product Profiles and their impact on product development.
Expertise in conducting regulatory due diligence and managing compliance risks.
Demonstrated success in early FDA/EMA/UK engagements and interactions.
Solid understanding of orphan drug and pediatric regulatory strategies.
Excellent communication, negotiation, and presentation skills.
Join our dynamic team and contribute to the success of groundbreaking medical innovations that positively impact lives worldwide. If you are an ambitious and detail-oriented professional with a passion for regulatory affairs and compliance, we invite you to apply for this exciting opportunity.
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