Regulatory Affairs Manager

About the Role

Our client is seeking a seasoned Regulatory Affairs Manager to lead their regulatory strategy and compliance efforts in Edinburgh . This position is integral to ensuring that all pharmaceutical products meet the rigorous standards set by regulatory bodies across key markets. You will be responsible for overseeing the preparation and submission of regulatory documentation, liaising with health authorities, and providing expert guidance on regulatory requirements throughout the product lifecycle. This role offers a significant opportunity to shape regulatory strategies and contribute to the successful market access of innovative pharmaceutical products in a leading company.

Key Responsibilities

• Develop and execute regulatory strategies for product development, registration, and lifecycle management in compliance with global regulations.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities such as the MHRA, EMA, and FDA.
• Serve as the primary point of contact for regulatory agencies, responding to queries and managing communications effectively.
• Provide regulatory guidance and support to internal teams, including R&D, clinical, manufacturing, and marketing.
• Monitor and interpret evolving regulatory legislation and guidelines, assessing their impact on company operations and product portfolios.
• Ensure adherence to all relevant regulatory policies and procedures, maintaining a high standard of compliance.

Requirements

• Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, Law, or a related scientific discipline.
• Minimum of 7 years of progressive experience in Pharmaceutical Regulatory Affairs .
• Proven success in managing regulatory submissions and interactions with major health authorities.
• Comprehensive knowledge of international pharmaceutical regulations, guidelines, and submission requirements.
• Strong leadership, strategic thinking, and project management skills.
• Excellent written and verbal communication abilities, with strong negotiation skills.

Benefits

• Competitive salary package and potential for executive bonuses.
• Comprehensive health insurance, including private medical and dental coverage.
• Generous pension scheme and life insurance benefits.
• Opportunities for continued professional development and leadership training.
• A dynamic role in Edinburgh , contributing to global regulatory success and offering a blend of office and remote work flexibility.