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Job Details

Freelance Regulatory Affairs Manager - Freelance

Company: Barrington James Clinical
Location:
Reference: MTMRFLRA-1104
Closing Date: 11 May 18
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

Freelance Regulatory Affairs Manager - CMC - Geneva

Requirements:

Freelance Regulatory Affairs Manager - Freelance

I am currently working with an innovative Pharmaceutical company looking for expand their Regulatory department with a highly experience Regulatory Affairs Manager within the CMC field. The right candidate will benefit from a full time 4 month contract with a potential of more project moving forward.

 

Responsibilities:

  • Manages activities relating to development of regulatory documents and other operational documents as appropriate as well as any updates/amendments to those documents
  • Actively collaborate and liaise with other development functions on biosimilar issues, e.g. Technical Development, Non-clinical and Clinical Development, external consultants, and participate in cross-functional teams
  • Prepare, coordinate and compile (quality) parts of regulatory dossiers for worldwide submissions including responses to questions from regulatory authorities according to project progress and requirements
  • Ensure flow of information is tracked and actively monitors progress identifying issues for resolution
  • Assure correct document formatting according regulatory requirements as well as filing and archiving of documentation

 

Qualifications

  • MSc/PhD in biotechnology, biology or biochemistry (or equivalent)
  • 3-5 years industrial experience in regulatory topics both for regulatory affairs and regulatory CMC with background on biotech products, experience in GMP or clinical matters of biotech products
  • Development experience with biological drugs, ideally with biosimilars
  • Excellent planning, communication, documentation and organizational skills with hands-on mentality
  • Knowledge of relevant legislation and international guidelines for regulatory affairs
  • Very good English (written and oral)

For further information about this role and to be considered as an applicant, please get in touch with Matias Martin-Baeza at mmbaeza@barringtonjames.com or call +44 1293 776644

Apply for this job: Freelance Regulatory Affairs Manager - Freelance

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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