SRG Clinical

Senior Regulatory Affairs Manager- Oncology- 28082

27 Nov 2018
25 Dec 2018
Contract Type
My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Affairs Senior Manager- Oncology on an initial 6 month contract to be based in their offices in either Middlesex or Cambridge.

The Role:

This role will provide regional regulatory support across multiple 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 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)

Skills/Experience Required:

Demonstrable experience acting as therapeutic area European Regulatory Affairs lead, defining and implement regulatory strategies and executional plans
• Practical Regulatory knowledge of regional legislation
• Experience with national legislation and regulations relating to medicinal products
• Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals

Preferred Requirements:
• Experience in oncology therapeutic area
• Experience working with biotechnology products

If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: or 01753 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.

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