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Regulatory Manager/Senior Manager Development

Location:
Essex
Company:
Apex International Recruitment Ltd

Description

DETAILS:

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

THE 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 job description available on application

THE 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 consultants

Preferences:

  • >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

TO APPLY:

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 alex@ apexrecruitment.com

To view our other vacancies, please visit our website on www.apexrecruitment.com

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.


This job was originally posted as www.totaljobs.com/job/89678566
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