Regulatory Affairs Manager

About the Role

Our client is seeking a seasoned Regulatory Affairs Manager to oversee regulatory submissions and strategies for their innovative pharmaceutical products. This role, based in the vibrant city of Southampton , is critical for ensuring timely approvals and market access for new medicines. You will lead a team of regulatory professionals, liaise with health authorities, and ensure ongoing compliance with global regulations. This is an exciting opportunity to drive regulatory success within a dynamic and forward-thinking pharmaceutical company, working within a flexible, hybrid arrangement.

Key Responsibilities

• Develop and implement regulatory strategies for product development and lifecycle management.
• Prepare and submit regulatory dossiers to health authorities (e.g., MHRA, FDA, EMA).
• Serve as the primary point of contact with regulatory agencies for assigned products.
• Ensure compliance with all applicable national and international regulations and guidelines.
• Review and approve promotional materials and product labeling for regulatory accuracy.
• Lead and mentor the regulatory affairs team, fostering professional development and high performance.

Requirements

• Master's degree or PhD in Pharmacy, Chemistry, Life Sciences, or a related discipline.
• Minimum of 6 years of experience in regulatory affairs within the pharmaceutical industry.
• Proven track record of successful regulatory submissions and approvals.
• In-depth knowledge of pharmaceutical regulations in key markets (e.g., UK, EU, US).
• Excellent communication, negotiation, and leadership skills.
• Ability to work effectively in a hybrid environment and travel as needed to Southampton and other locations.

Benefits

• Competitive salary and executive bonus opportunities.
• Comprehensive private medical insurance.
• Relocation assistance may be available.
• Generous pension scheme.
• Commitment to work-life balance and professional development.