Senior European Regulatory Affairs Specialist / Cambridge

We are sourcing a Senior European Regulatory Affairs Specialist on behalf of our Multinational Biotechnology Client on an initial 12-month contract located in Cambridge/Uxbridge.

Job Summary

As a member of the Global Regulatory Team (GRT), the successful candidate will be accountable for developing and executing regional regulatory strategies across the product lifecycle and managing effective agency interactions. The individual should have a proven track record supporting the diversity of regulatory procedures in the EU (inc. PIPs, variations, IMPDs, MAAs) and ability to work autonomously. The purpose of this role is to progress the client pipeline through timely regulatory approvals, including clinical trials for investigational medicinal products, as well as approved medicinal products, and to ensure timely regulatory compliance with such approvals.

Key Responsibilities

• Defines and advises 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 optimize 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 company 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 interactions.

Qualifications & Experience

• Demonstrable experience acting as therapeutic area European Regulatory Affairs lead, defining and implement regulatory strategies and executional plans.
• Practical Regulatory knowledge of regional legislation.
• Previous experience 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.