Regulatory Affairs Specialist - Pharmaceuticals

About the Role

Our client, a prominent player in the pharmaceutical sector, is looking for a skilled Regulatory Affairs Specialist to join their team based in Sunderland . This role is integral to ensuring that our client's pharmaceutical products meet all necessary legal and scientific requirements for market approval and continued compliance. You will navigate complex regulatory landscapes, working collaboratively with internal departments and external agencies to facilitate the timely submission and approval of new drug applications and variations. This position offers a significant opportunity to impact patient access to vital medicines in the Tyne and Wear region.

Key Responsibilities

• Prepare, compile, and submit regulatory documentation for new marketing authorization applications (MAAs) and variations.
• Maintain and update product registrations in relevant national and international databases.
• Liaise with regulatory authorities (e.g., MHRA) to address queries and facilitate the approval process.
• Monitor changes in the regulatory environment and assess their impact on the company's products and strategy.
• Ensure compliance of product labeling, advertising, and promotional materials with regulatory requirements.
• Support regulatory aspects of product lifecycle management, including post-approval changes and renewals.

Requirements

• Degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Proven experience in regulatory affairs within the pharmaceutical industry, with knowledge of UK and EU regulations.
• Strong understanding of drug development processes and regulatory submission requirements.
• Excellent written and verbal communication skills, with the ability to clearly articulate complex regulatory information.
• Detail-oriented with strong organizational and project management skills.
• Familiarity with regulatory submission software and databases.

Benefits

• Competitive salary and performance-related bonus structure.
• Hybrid working model offering a balance between office and remote work.
• Comprehensive health and wellness benefits, including private medical insurance.
• Contributory pension scheme and life assurance.
• Opportunities for professional development and training in a rapidly evolving field.