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Senior Manager Regulatory Affairs, Cambridgeshire
Client:
Quanta part of QCS Staffing
Location:
Cambridgeshire, United Kingdom
Job Category:
Other
EU work permit required:
Yes
Job Reference:
982ce4852d4a
Job Views:
6
Posted:
03.03.2025
Expiry Date:
17.04.2025
Job Description:
Senior Manager Regulatory Affairs - Pharmaceuticals - Cambridge
Our client, a globally recognised pioneer in Biotechnology, is recruiting for the position of Senior Manager Regulatory Affairs. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to strive for solutions. This is your chance to join them on their global mission to better the lives of those affected by disease and illness.
Responsibilities:
1. Define and advise the GRT on regional considerations in developing creative regulatory strategy.
2. Ensure European regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
3. Develop and implement regulatory strategy and executional plans, and manage regulatory submissions (e.g., clinical trial and marketing applications) for assigned products in accordance with global filing plans, core labelling documents, and regulatory requirements.
4. Lead development of regional regulatory documents and meetings, and provide regulatory advice on regional regulatory requirements, mechanisms to optimise product development, and to maintain compliance.
5. Co-ordinate and provide guidance to company responses to requests from regulatory authorities, e.g., Response to Questions (RTQs).
6. Communicate and ensure alignment with proposed regulatory strategies such that expectations, regulatory risks, and mitigations are characterised and understood.
7. Estimate the likelihood of regulatory success and timelines based on proposed strategies; discuss with GRT and line management, and communicate to stakeholders.
8. Maintain an awareness of new and developing legislation, regulatory policy, and technical regulatory guidance relating to products, and evaluate and communicate impact.
9. Act as contact and create relationships with agency staff on specific product assignments and document and communicate details and outcomes of regulatory agency interaction.
Basic Requirements:
1. Demonstrable experience acting as therapeutic area European Regulatory Affairs lead, defining and implementing regulatory strategies and executional plans.
2. Practical regulatory knowledge of regional legislation.
3. Experience with policies, procedures, and SOPs.
4. Experience with national legislation and regional regulations relating to medicinal products.
5. Understanding of the regional regulatory procedures for CTAs, MAs, post-approval changes, extensions, and renewals.
6. Understanding of drug development.
7. Strong knowledge of and experience in the regional regulatory environment in relevant product area and development stage.
8. Comprehensive understanding of regulatory activities, touch points, and how they affect projects and processes.
9. Experience of working directly with the EMA and Centralised Procedure.
10. Experience in Inflammation, Cardiovascular, Bone, Therapeutic Area.
11. Experience working with biotechnology products.
If this role is of interest to you, please apply now!
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