Senior Regulatory Affairs Manager

Job Ref: J26030
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 26 March 2018
  • Camden, London, England, UK
  • Competitive
  • Neal Panting
  • 01753 589601

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Role Responsibilities:* Involved with development of regulatory strategies for new products.* Undertake co-ordinating role to prepare for, attend and provide regulatory expertise at regulatory authority meetings* Prepare and submit CTAs, orphan drug designations and MAAs to meet company goals and timelines * Review all regulatory agency compliance materials to guarantee accuracy, timeliness, comprehensiveness, and adherence to regulatory standards.* Maintain current knowledge of relevant EU regulations including proposed and final rules.* Act as a company expert in EU Regulatory Affairs, providing updates, support and education as required* Provide EU regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products. * Liaise with external collaborators and manage external resources e.g. CROs* Contribute to the establishment of the global regulatory function and organisation of company regulatory data* Play an instrumental role in the global regulatory affairs function through active participation and collaborationDemonstrated skills and competencies:* Extensive experience in EU Regulatory Affairs including significant industry experience (experience in Global territories is desirable)* Scientific qualification - minimum Bachelor's Degree (post graduate qualification preferred) * Hands on experience within immunology, cell/gene therapy or oncology advantageous* Regulatory experience with new product development for biotechnology products.* Thorough understanding of EMA and national European regulation * Ability to work in a standalone role.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.