Regulatory Manager / Senior Manager (Devolpment)

Competitive salary and benefits
03 Oct 2019
02 Nov 2019
Full Time
Contract Type
Experience Level


  • Full-time permanent position
  • Office based in Essex
  • Competitive package
  • Global pharma company



The Regulatory Manager/Senior Manager will provide the following expertise-based services:

  • 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 job description available on application




  • 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 consultants


  • >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


Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email

To view our other vacancies, please visit our website on

Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.

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