Senior Manager Regulatory Affairs – Pharmaceuticals – Cambridge
Our client, a globally recognised pioneer in Biotechnology, are 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 stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness.
Responsibilities:
Define and advise the GRT on regional considerations in developing creative regulatory strategy
Ensures European regional needs are well defined and implemented in collaboration with relevant regional stakeholders
Develops and implements regulatory strategy and executional plans, and manages regulatory submissions (e.g., clinical trial and marketing applications) for assigned products in accordance with global filing plans, core labelling documents and regulatory requirements
Leads development of regional regulatory documents and meetings, and provides regulatory advice on regional regulatory requirements, mechanisms to optimise product development and to maintain compliance
Co-ordinates and provides guidance to company responses to requests from regulatory authorities, e.g., Response to Questions (RTQs)
Communicates and ensures alignment with proposed regulatory strategies such that expectations, regulatory risks, and mitigations are characterised and understood.
Estimate the likelihood of regulatory success and timelines based on proposed strategies; discuss with GRT and line Management, and communicates to stakeholders
Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to products, and evaluates and communicates impact
Act as contact and create relationships with agency staff on specific product assignment and document and communicate details and outcomes of regulatory agency interaction.
Basic Requirements:
Demonstrable experience acting as therapeutic area European Regulatory Affairs lead, defining and implement regulatory strategies and executional plans
Practical Regulatory knowledge of regional legislation
Working with policies, procedures, and SOPs
Experience with national legislation and regional regulations relating to medicinal products
Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions, and renewals
Understanding of drug development
Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes
Experience of working directly with the EMA and Centralised Procedure
Experience in Inflammation, Cardiovascular, Bone, Therapeutic Area
Experience working with biotechnology products
If this role is of interest to you, please apply now!
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