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Regulatory Manager/ Senior Manager (Development) New


Regulatory Manager/ Senior Manager (Development) New

Job reference

Company Name

Apex Recruitment


CM1, Chelmsford, Essex

Industry sector


Job type

Permanent | Full Time


Posted date



DETAILS:* Full-time permanent position* Office based in Essex* Competitive package* Global pharma companyTHE ROLE:* Point of contact for agency interaction* Provide expert EU regulatory strategy* To be a client lead* Provide leadership in scientific advice meetings at national agencies and EMA* Project management/lead responsibilities* Client facing with strong communication skills, willing to travel* To assist the company in providing regulatory knowledge to business development colleagues during bid defence* To lead EMA procedures including orphan applications, PIP’s, scientific advice briefing documents, etc.Full available on applicationTHE CANDIDATE:Essentials* Degree or higher in Chemistry, Biochemistry, Biology or related scientific disciplines* 3+ years European regulatory affairs experience with demonstrable experience in liaising and negotiating with regulatory authorities* Demonstrable experience in scientific advice meetings, CTA, orphan applications and/or PIPs* Strong understanding of the regulatory environment including guidelines* Ability to work under pressure and achieve timely submission and regulatory approvals* Excellent computer skills* Collaborative approach and able to work effectively with matrix-based teams involving internal staff, client teams that include independent consultantsPreferences:* >5 years of experience in regulatory affairs based activities and regulatory authority interactions* Exposure to MAA dossier writing and submission procedures* US FDA facing experience* Only candidates with existing right to work in the UK/EU will be considered

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Chelmsford, Chelmsford, England, Essex, United Kingdom

  • Ad ID:  14901451
  • Ad Type:  Offered
  • Posted on:  04/07/2020, 02:53
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