Blackfield Associates are seeking a Regulatory Affairs Director to lead lifecycle regulatory activities for a large established products portfolio. This role is pivotal in ensuring compliance with European regulatory requirements, developing and implementing regulatory strategies and continued portfolio expansion via acquisition.

Key Responsibilities:

• Develop and implement EU regulatory strategies for established products.
• Lead and manage interactions with regulatory authorities across EU and UK.
• Drive lifecycle management activities including authoring and submission of variations, such as Type 1,1b, Type 2 variations, safety updates, SmPC and Package Leaflet changes
• Collaborate cross-functionally with KOLS
• Monitor and respond to regulatory changes in global markets, sharing insights and best practices.
• Lead and coach Regulatory Professionals, setting clear objectives and fostering development aligned with company goals.

Qualifications & Experience:

• Significant (Minimum 8 years) experience managing lifecycle regulatory activities for established products in Regulatory
• Previous held Regulatory management positions such as Lead or Associate Director
• Strong expertise in authoring and submitting regulatory variations, including safety and quality-related changes.
• Advanced degree in a life science discipline desirable
• In-depth knowledge of EU and UK regulatory procedures (MRP/DCP/CP and NP).
• Proven experience in technology and marketing authorisation transfers.
• Experience gained in a fast paced environment
• Familiarity with CMC and clinical variation classifications and submission requirements.
• Experience working in a matrix environment with cross-functional collaboration.
• Strategic thinker with the ability to navigate complex regulatory landscapes.
• Previous line management experience would be desirable
• Must be a clear, concise communicator

This is a full time permeant position. Hybrid working. Unable to sponsor, all applicants must hold valid right to work in the UK and have the ability to attend the office.