Director of Regulatory Affairs

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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.
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Location:
Slough, Berkshire, Berkshire; South East England; England, United Kingdom
Job Type:
FullTime

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