Regulatory Affairs Director

About the Role

Our client is a dynamic and growing pharmaceutical company with a robust pipeline of innovative products. We are seeking a strategic and experienced Regulatory Affairs Director to lead our regulatory operations in Nottingham . This senior leadership position will be responsible for developing and implementing global regulatory strategies, ensuring compliance with all relevant health authority requirements, and guiding the regulatory submission process for new drug applications and lifecycle management. You will play a pivotal role in shaping the company's regulatory approach and ensuring successful market access for our critical medicines, fostering a culture of regulatory excellence and compliance.

Key Responsibilities

• Develop and execute comprehensive global regulatory strategies for product development and lifecycle management.
• Lead and manage the preparation and submission of regulatory dossiers to health authorities worldwide (e.g., FDA, EMA, MHRA).
• Provide expert regulatory guidance and interpretation of regulations to R&D, clinical, manufacturing, and commercial teams.
• Oversee regulatory compliance activities, ensuring adherence to all applicable laws and guidelines.
• Represent the company in interactions with regulatory agencies and industry associations.
• Manage and mentor the regulatory affairs team, fostering professional development and high performance.

Requirements

• Master's or PhD in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 10 years of progressive experience in Regulatory Affairs within the pharmaceutical industry.
• Proven track record of successfully leading regulatory strategy and submissions for global markets.
• Extensive knowledge of global regulatory requirements, including FDA, EMA, and other key agencies.
• Strong leadership, strategic thinking, and excellent communication skills.
• Demonstrated ability to manage complex projects and teams effectively.

Benefits

• Executive-level salary and significant bonus potential.
• Comprehensive benefits including premium health, dental, and life insurance.
• Generous pension scheme and stock options.
• Exceptional opportunities for career advancement and leadership.
• A highly innovative and collaborative work environment.