Senior Manager Regulatory Affairs

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Senior Manager Regulatory Affairs, Cambridge

Client: Quanta part of QCS Staffing

Location: Cambridge, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: 982ce4852d4a

Job Views: 8

Posted: 26.04.2025

Expiry Date: 10.06.2025

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:

• Define and advise the GRT on regional considerations in developing creative regulatory strategy.
• Ensure European regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
• Develop and implement regulatory strategy and executional plans, manage regulatory submissions (e.g., clinical trial and marketing applications) in accordance with global filing plans, core labelling documents, and regulatory requirements.
• 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.
• Coordinate and guide company responses to requests from regulatory authorities, e.g., Response to Questions (RTQs).
• Communicate and ensure alignment with proposed regulatory strategies, characterising and understanding expectations, risks, and mitigations.
• Estimate the likelihood of regulatory success and timelines based on proposed strategies; discuss with GRT and line management, and communicate to stakeholders.
• Maintain awareness of new and developing legislation, regulatory policy, and technical guidance relating to products, evaluate and communicate impact.
• Act as contact and create relationships with agency staff on specific product assignments, and communicate details and outcomes of regulatory agency interactions.

Basic Requirements:

• Experience acting as therapeutic area European Regulatory Affairs lead, defining and implementing regulatory strategies and plans.
• Practical knowledge of regional legislation.
• Experience working with policies, procedures, and SOPs.
• Understanding of national legislation and regional regulations relating to medicinal products.
• Understanding of regulatory procedures for CTAs, MAs, post-approval changes, extensions, and renewals.
• Understanding of drug development processes.
• Strong knowledge of and experience in the regional regulatory environment relevant to the product area and development stage.
• Comprehensive understanding of regulatory activities and their impact on projects and processes.
• Experience working directly with the EMA and Centralised Procedure.
• Experience in Inflammation, Cardiovascular, Bone, Therapeutic Area.
• Experience working with biotechnology products.

If this role interests you, please apply now!