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.