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Regulatory Affairs Manager
3 months ago
Job Title: Regulatory Affairs Manager
Job Type: 12-Month Contract (inside IR35)
Location: Uxbridge or Cambridge – 1 day on-site per month
Rate: £45 to £55 per hour (PAYE)
This role will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), they will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.
To ensure the business acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products to ensure timely regulatory compliance with above approvals, as requested this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade)
- Advising the GRT on regional considerations in developing strategy ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
- May manage one or more regional leads or support roles Strategy and Execution Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within portfolio in compliance with global filing plans and local regulatory requirements.
- Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Leads development of regional regulatory documents and meetings in accordance with GRT strategy
- Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and paediatric plan)
- Directs the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Communicate and ensure alignment of regional management before GRT strategy decisions
- Partner with regional management and peers to ensure consistency in procedures and agency interactions Regulatory Research Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to the products.
- Knowledge and Skills Regulatory knowledge in regional legislation Working with policies, procedures and SOPs Experience with national legislation and regulations relating to medicinal products Understanding of the regional regulatory procedures for CTAs, MAs, post-approval changes, extensions and renewals.
Requirements:
- A suitable degree in life sciences at minimum.
- At least 3+ years of experience in Regulatory Affairs including supporting both pre and post-approval activities.
- Previous experience driving EU/global regulatory strategies.
- Experience submitting CTA, IND, IMPD, and MAAs.
For more information please reach out to lucy.kirkaldy@cpl.com
Please note you must be based in the UK and have the FULL right to work in the UK.
