Manager Regulatory Affairs

Work location – Halifax, Nova Scotia OR Quebec City, Quebec

Job Summary

We are searching for an experienced Manager Regulatory Affairs to join one of Canada’s leading life sciences organizations.  Ideally based in Halifax Regional Municipality, the Manager Regulatory Affairs will have the overall responsibility of developing and managing our client’s pharmacovigilance activities. This position reports to the Vice President.

Key Responsibilities:

  • Develop and manage the pharmacovigilance activities.
  • Reporting Adverse events to authorities or partners, interacting with partners and responding to information requests
  • Preparing monthly and annual reports
  • Developing a consolidated database
  • Supports the Vice President in the review of documentation associated to the clinical and non-clinical development
  • Actively contribute to the regulatory operations, including preparation of regulatory submissions, meeting requests and briefing documents, and other interaction with regulatory agencies.
  • Collaborate with the team to develop internal tools for the preparation of eCTD compliant documents

 

Our Ideal Candidate Brings:

  • Bachelor of Science
  • A minimum of 5 years of experience in regulatory affairs and/or regulatory operations supporting clinical and pharmacovigilance activities.
  • 2 years’ hands on experience in preparation of eCTD compliant regulatory submissions and e-Publishing
  • Experience in development of biologics (vaccine, oncology)
  • Adaptability and Detail Orientated
  • In depth understanding of the regulation/requirements supporting the development of biologic, oncology and/or vaccine in Canada, USA and Europe
  • Excellent written and verbal English communication skills

For additional details regarding this unique opportunity, please send your resume to [email protected] or call directly: 902 405 3607

Summit Search Group would like to thank everyone who applies but only those whom match the requirements will be given follow up communications.

Job ID

SM120

City

Halifax, NS

Remuneration

Depends on experience

Recruiter

Apply Online

If your qualifications are a match for this position please apply online for immediate consideration. Thank you for your application.

Position:

Manager Regulatory Affairs