Regulatory Affairs Manager - Western Europe - Oncology

Regulatory Affairs Manager - Western Europe - Oncology
  • Competitive
  • Permanent
  • Maidenhead, Berkshire, England, UK Maidenhead Berkshire UK SL6 4UB
Job Ref: J2162625
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 09 November 2021
SRG are currently looking for an Associate Director for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team.

SRG are currently looking for an Associate Director, Regulatory Affairs for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team to be based at their office in Berkshire.

The Role:The Associate Director, Regulatory Affairs is an experienced regulatory professional with proven track record of leading end-to-end strategic planning, coordination, and execution of initial marketing authorisation application/s and new indications in Europe. The Associate Director is the lead contributor to regulatory strategy for Europe and expected to clearly identify submission pathway, risks and opportunities to Global Regulatory Project Team (GRPT) and cross-functional teams, working flexibly within Europe and other regions to ensure successful execution of the regulatory strategy. Key Responsibilities:* Define and implements regulatory strategies, risk assessment & deliverables for early, late development compounds and marketed products in the Oncology / Haematology Therapeutic Area for the Western Europe Area region (including Israel, Switzerland, Turkey and the UK). * Identify and advocate region's requirements in the overarching global regulatory strategy; develop risk assessment of product/s and ensures it is considered at the GRPT.* Effectively lead planning, preparation and delivery of complex submissions throughout product's life cycle from regional perspective including PIPs* Understand the European regulatory framework, including regional trends, for initial MAA and follow-on submissions for small and large molecules across the region* Assess scientific data provided by specialist units for registration purposes against Western Europe regulatory requirements, identify gaps and develop mitigation strategies. Ensure effective presentation of data, complete and timely responses (including PIPs).* Maintain active awareness of EU legislation/s and assess its impact on the business and R&D programmes jointly with Regulatory Policy & Intelligence team. Contribute to Agency policy shaping through trade associations and contribute to internal and external process improvement * Share best practices and procedural experiences from interactions with health authorities with GRS and operate seamlessly in a highly dynamic environment * Represent the Area/Affiliate regulatory requirements and interests (Regulatory Affairs affiliates and commercial) on the GRPT * Primary Regulatory Affairs interface with Commercial lead/s. Represent Regulatory Affairs on the Brand Teams (providing strategic insight for registration, ensuring the business needs are met by anticipating and mitigating regulatory risks, assessing probability of success for submission, approval by product).* Primary interface with Regulatory Agencies and Regulatory Affairs personnel in the affiliates.* Ensure internal and external compliance for assigned products* Provide coaching and mentoring to regulatory project managers and senior project managers Skills/Experience Required:* BSc/MSc Degree in Science discipline* Thorough knowledge of drug development in Europe * Extensive regulatory experience within the biopharmaceutical industry in Europe.* Experience in leading regulatory activities at early and late development stages in Europe. * Demonstrated ability to strategically think, influence and innovate* Strong leadership presence and solution driven style.* Proven leadership, including experience in leading health authority interactions in Europe at early and late-stage development including paediatric development * Proactive verbal and written communication style at all levels. Fluent in English* Ability to work independently with minimal supervision in matrix environment * Experienced in working effectively across diverse cultures and in complex matrixed environment.Desirable Experience:* Recent experience in organising and leading integrated scientific advice with EMA and EUnetHTA desirable. * Strong interpersonal, managerial and organisational skills.If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441615077288

09/12/2021 11:21:36
GBP 0.00 0.00 Annum
Contact Consultant:
Corinne Laurence

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