Senior Regulatory Manager - 12 month contract

Posted 6 days 10 hours ago by Key People Limited

£50 - £70 Hourly
Contract
Not Specified
Consulting & Corporate Strategy Jobs
Hertfordshire, St. Albans, United Kingdom, AL1 1
Job Description

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...... click apply for full job details

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