Regulatory Affairs Senior Manager
CK Group are recruiting for a Regulatory Affairs Senior Manager to join a biopharmaceutical company either remotely or at their site based in Uxbridge on a contract basis for 12 months.
Company: Our client is committed to unlocking the potentialof biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
Location: This Regulatory Affairs Senior Manager role will be either remote or based at our clientssite in Uxbridge, Greater London.
Regulatory Affairs Senior Manager Role:
- 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.
- Strategy and Execution Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within the company portfolio in compliance with global filing plans and local regulatory requirements.
- Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Lead development of regional regulatory documents and meetings in accordance with GRT strategy- Provide regulatory direction on regional regulatory mechanisms to optimize product development.
- Regulatory knowledge in regional legislation.
- 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.
- Understanding of drug development Scientific/Technical Excellence.
- Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage.
Apply: For more information or to apply for this Regulatory Affairs Senior Manager position, please contact Lucy or Andy on 01438 870011 or email firstname.lastname@example.org, quoting job ref 48961.
It is essential that applicants hold entitlement to work in the UK.