Senior Regulatory Manager - 12 month contract

Employer
Key People Limited
Location
England, London
Salary
£50 - £70 per hour
Closing date
22 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
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This role will support one or more oncology products from a European regulatory perspective. As a member of the Global Regulatory Team (GRT), you will define the regulatory strategy and support the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.

Responsibilities:

- 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)
- 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
- Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals , compassionate use and pediatric 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.
- Develop predictions for expectations and risks associated with outcomes by regulatory agencies Ensure regulatory product compliance for product (e.g. IMR, PMCs, paediatric and other agency commitments)
- 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
- Evaluates and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling Health Authority Interactions

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.
- Understanding of drug development Scientific / Technical Excellence
- Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
- Cultural awareness and sensitivity to achieve results across both regional country and International borders.

For further details please contact Tim Barratt on 01727 817 626 or email tbarratt@keypeople.co.uk

International recruitment solutions

Key People is a truly international operation with offices in the UK, Switzerland and Iraq

We have developed working relationships with many of the FTSE 100 companies, including some of the world's most recognised global brands in the pharmaceutical, Oil, Gas, Energy and engineering industries.

Our dedication to both employers and candidates, and our vast experience enables us to provide superior solutions and effective results. We're proud to be a private company driven by our commitment to our customers and we are constantly exploring new markets in our bid to become the number one recruitment agency for customer satisfaction across a number of industry sectors.

Contact Us
  • Catherine House
  • Adelaide Street
  • St Albans
  • AL3 5BA
  • GB
  • +44 (0) 1727 811634
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