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Regulatory Affairs Senior Manager

Job LocationLondon
EducationNot Mentioned
Salary£55,000 - £70,000 per annum, inc benefits
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Regulatory Affairs Senior Manager, ATMP, Cell Therapy, Gene Therapy, EU, ODD, PIP, CTAs, INDs, NDAs Your new companyThis UK-based ATMP focused scientific research centre are looking for a Regulatory Affairs Senior Manager to expand on their tight-knit development team. The company specialise in work across highly advanced Cell and Gene therapies across early stage development through to manufacturing. They are the leaders of the ATMP work across the UK. This role will be based in Central London.Your new roleYou will be responsible for the preparation of regulatory submissions for advanced therapy medicinal products, acting as Regulatory Affairs Senior Manager. You will act as an expert consultant within the field, having an extensive background in both Regulatory Affairs as well as Cell and Gene Therapy processes. Additionally, this role will entail working across Regulatory Strategies in CMC, CTAs, NDAs, etc. This is a high-responsibility role as it entails reporting directly to the Head of Regulatory Affairs as well as supporting and mentoring junior Regulatory employees. Additionally, this role will give you ample opportunity to have full ownership of Regulatory processes.Main Responsibilities

  • Advanced Therapy Medicinal Products Regulatory Submissions (Cell and Gene Therapies)
  • Regulatory Strategy development across ODDs, PIPs, CMC
  • Early stage development processes: Clinical Development, CTAs, NDAs, INDs
  • Submissions towards EU (EMA) + US (FDA) Regulatory markets
  • Regulatory Compliance
  • Maintaining knowledge of Regulatory Intelligence + Updates
  • Junior employee mentorship
  • What youll get in returnYou will reap great benefits as the development opportunities are incomparable, as you will not be siloed in and have full ownership of Regulatory processes. You will get the opportunity to contribute to highly technical Cell and Gene Therapy processes in Regulatory Affairs, developing on your own skill-set in a totally unique setting. What you need to do nowIf youre interested in this role, click apply now to forward an up-to-date copy of your CV, or call us now.If this job isnt quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. Required skills
  • EU
  • Gene Therapy
  • PIP
  • Cell Therapy
  • ODD
  • CTAs
  • INDs
  • ATMP
  • NDAs
  • Regulatory Affairs Senior Manager
  • Keyskills :
    Gene Therapy PIP Cell Therapy ODD CTAs INDs ATMP NDAs Regulaty Affairs Seni Manager

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