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Senior Regulatory Affair Manager – 6 month freelance contract – Top 10 – Uxbridge - Hourly rate negotiable
ARM Life Sciences are currently engaged in a search for Senior Regulatory Affair Manager to join a Top 10 Biopharmaceutical company based in Uxbridge. The main aim for this role would be to support clinical trials for investigational medicinal products as well as market commercially approved medical products.
Please see below a breakdown of the project and requirement –
Key Activities Strategy and Execution
- Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products.
- Implement 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 to the strategy.
- Working closely with labelling Group to define commercial objectives
- Obtains and maintains Clinical Trial Authorizations (CTA) and Marketing Application approvals
- Communicates regulatory strategies in accordance to team members.
- Analyse the regulatory success based on proposed strategies keeping a strong line of communication with the team and line management
- Analyse the likelihood of risks associated with outcomes by regulatory agencies
- Communicate and ensure alignment of regional management.
- Health Authority Interactions
- Supports communication and collaboration between direct reports who are regional leads and regional head for program issues requiring next level engagement
- Provides managerial leadership & direction to assigned team allowing appropriate prioritization of resources to achieve goals.
This role will be based on a 6 month freelance contract with good scope to extend. You will be paid via a LTD company or umbrella set up. Rates of pay are negotiable. If you are interested in hearing more please contact Vik Patel at ARM Life Sciences on 02392 458031 or email me on email@example.com
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