Senior Regulatory Consultant- Oncology

Job Ref: J27738
Sector: Clinical
Sub-sector: Biotech/Life Sciences
Date Added: 20 July 2018
  • Cambridge, Cambridgeshire, England, UK
  • Competitive
  • Neal Panting
  • 01753 589601

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My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a EU Regulatory Affairs Manager- Oncology on an initial 6 Month basis to be based at their offices in Cambridge.The Role:This role will provide regional regulatory support for one or more products. As a member of the Global Regulatory Team the incumbent 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. Key Responsibilities:* Define and advise 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 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 development and to maintain compliance * Co-ordinates and provides guidance to company responses to requests from regulatory authorities * 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 line Management, and communicates to stakeholders Skills/Experience Required:Education*Life Sciences Degree qualified. KnowledgeBasic Requirements: * Demonstrable experience acting as therapeutic area European Regulatory Affairs lead, defining and implement regulatory strategies and executional plans * Understanding of the regional regulatory procedures for CTAs, MAs, extensions and renewals * Experience in oncology therapeutic area * Experience working with biotechnology products If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

19/08/2018 16:03:26