i-Pharm Consulting

Regulatory Affairs Manager

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Job Location

London, United Kingdom

Job Description

Exciting Opportunity: Regulatory Affairs Manager (12-Month Contract)


We’re looking for a Regulatory Affairs Manager to join our dynamic global team and support key regulatory activities in oncology clinical trials and marketed products. This is a 12-month contract role based in the UK, offering the chance to work with a multinational team and take ownership of regulatory strategies in a global company.


What You’ll Do:

  • Lead regional regulatory strategies for clinical trials and marketed products in the EU
  • Collaborate with global teams and regulatory agencies to ensure compliance
  • Play a key role in developing and managing submissions, labelling, and product life cycles
  • Provide insights to the Global Regulatory Team (GRT) and Global Development Team (GDT) on regional regulatory requirements
  • Support or manage a regional team and help drive agency interactions


What We’re Looking For:

  • 5+ years of independent experience in regulatory affairs, supporting Clinical Trials (preferably in oncology)
  • Strong knowledge of EU regulations and experience with CTAs, MAs, and regulatory submissions
  • Exposure to marketed products – you’ve supported labelling or contributed to regulatory documents like Module 1 of the CTD
  • Experience working in a global environment with cross-functional teams


Be part of a multinational team with a collaborative and inclusive culture - Flexibility with a mix of virtual and occasional onsite meetings - Opportunity to work on cutting-edge therapies and have a real impact in oncology clinical trials - Gain invaluable experience with a global regulatory leader in the biotech sector


#RegulatoryAffairs #ClinicalTrials #Oncology #Biotech #PharmaJobs #RegulatoryCompliance



Location: London, GB

Posted Date: 10/10/2024
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Contact Information

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i-Pharm Consulting

Posted

October 10, 2024
UID: 4888212302

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