Regulatory Affairs Manager

Location
Essex (GB)
Salary
Competitive salary and benefits
Posted
11 Jul 2019
Closes
01 Aug 2019
Ref
1107RAM
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

DETAILS:

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

 

THE ROLE:

  • The Regulatory Manager/Senior Manager provides development stage advice to internal staff and to clients for a broad range of programmes.
  • Provide EU regulatory affairs advice to clients developing a wide variety of medicinal products. Lead EMA procedures including orphan applications, PIPs and Scientific Advice.
  • Provide expert EU regulatory strategy. Regulatory lead and point of contact for national agency and EMA interactions.
  • Advise global clinical development teams in the requirements for EU based programmes, and to integrate with other regional experts.

Full job description available on application

 

THE CANDIDATE:

  • 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.
  • Client are considering candidates from Associate Reg Affairs Manager through to Senior Reg Affairs Manager level.
  • 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.

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