Regulatory Affairs Manager Clinical Trials

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

DETAILS:

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

 

THE ROLE:

  • Management of project work/project lead for assigned Client(s).
  • Preparation and/or coordination of CTAs and/or substantial amendments.
  • Responsibility for maintaining standards including (but not limited to) QC of CTA team’s work. Maintenance of working processes and CT Management Plan.
  • Maintaining an awareness of the EU Regulatory landscape and changing regulatory requirements. Assist in the development and training of junior employees, as required.
  • Preparation and project management of CTAs.
  • Preparation and/or review of CT application forms (including IRAS Forms), ARSAC submissions.

Full job description available on application

 

THE CANDIDATE:

  • 5+ years clinical trials experience (less for senior associate level).
  • Strong understanding of the EU regulatory environment including guidelines.
  • In depth knowledge of all CT application types.
  • Ability to work under pressure and achieve timely submission and regulatory approvals
  • Client will consider candidates from Senior Reg Affairs Associate CTA level upwards.
  • 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.