Regulatory Affairs Manager

About the Role

Our client is seeking a seasoned Regulatory Affairs Manager to lead their regulatory strategy and operations team in Sheffield . This key leadership role involves ensuring compliance with all national and international pharmaceutical regulations, managing regulatory submissions, and interfacing with health authorities. You will provide strategic guidance on regulatory matters, oversee the development and execution of regulatory plans, and manage a team of regulatory affairs professionals. This position requires strong leadership and a deep understanding of the regulatory landscape to drive the company's product development and market access goals.

Key Responsibilities

• Develop and implement global regulatory strategies for product development, registration, and lifecycle management.
• Lead the preparation and submission of regulatory dossiers (e.g., CTAs, MAAs, NDAs) to health authorities worldwide.
• Serve as the primary point of contact for regulatory agencies, managing all communications and responses.
• Oversee the regulatory review of promotional materials, labeling, and other product-related documents.
• Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, manufacturing, and marketing.
• Ensure compliance with current Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).

Requirements

• Degree in Pharmacy, Life Sciences, Chemistry, or a related field; advanced degree preferred.
• Minimum of 8 years of progressive experience in pharmaceutical regulatory affairs.
• Demonstrated experience in managing regulatory submissions and interacting with major health authorities (e.g., EMA, MHRA, FDA).
• Proven leadership skills with experience managing a regulatory affairs team.
• In-depth knowledge of pharmaceutical regulations and guidelines across key global markets.

Benefits

• Excellent competitive salary with comprehensive bonus structure.
• Robust health, dental, and vision insurance benefits.
• Generous pension scheme and life insurance.
• Significant annual leave allowance.
• Extensive opportunities for professional development and career advancement.