Regulatory Affairs Manager

About the Role

Our client is seeking a seasoned and strategic Regulatory Affairs Manager to lead their regulatory operations in Leeds . This senior position requires a deep understanding of the complex regulatory landscape for pharmaceuticals, with a focus on obtaining and maintaining marketing authorizations across key global markets. You will be responsible for developing and implementing regulatory strategies, ensuring compliance, and acting as the primary liaison with health authorities. This role offers the chance to shape regulatory approaches for innovative new medicines and contribute to global patient access, working within a respected pharmaceutical company known for its commitment to quality and ethical standards.

Key Responsibilities

• Develop and execute comprehensive regulatory strategies for product registration and lifecycle management in target markets.
• Prepare, review, and submit regulatory dossiers (e.g., CTD) to health authorities worldwide.
• Act as the main point of contact for regulatory agencies, responding to queries and managing regulatory inspections.
• Provide expert regulatory guidance to internal project teams, ensuring alignment with company objectives and regulatory requirements.
• Monitor changes in the regulatory environment and assess their impact on the company's products and strategies.
• Ensure the ongoing compliance of marketed products with all relevant regulatory standards and guidelines.

Requirements

• Master's degree or PhD in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• At least 7 years of progressive experience in pharmaceutical regulatory affairs.
• Proven track record of successful submissions and approvals of new drug applications (NDAs) or marketing authorization applications (MAAs).
• In-depth knowledge of global regulatory requirements (e.g., FDA, EMA, PMDA) and ICH guidelines.
• Strong leadership, negotiation, and communication skills, with the ability to influence stakeholders at all levels.

Benefits

• Competitive executive-level salary and bonus structure.
• Comprehensive medical, dental, and vision benefits.
• Generous annual leave and company pension contributions.
• Opportunities for international travel and professional development in Leeds .
• A dynamic and supportive work environment focused on innovation and compliance.