Manager, Regulatory Affairs

Description

We are hiring a Manager, Regulatory Affairs to join our great team! 

Reporting to the Director, Scientific and Regulatory Affairs, the Manager, Regulatory Affairs is responsible to ensure the services provided by the regulatory affairs department are conducted according to Innovaderm’s standard operating procedures, applicable regulations and good clinical practices and to the Sponsor’s satisfaction.

RESPONSIBILITIES:

The Manager, Regulatory Affairs:

• Ensures adequate resources (i.e., headcount, experience, training) to sustain activities of regulatory affairs group.
  • Ensures adequate training of regulatory affairs group and oversees regulatory affairs practices to ensure alignment of practices across the team through adoption and use of all process and technology tools.
  • Oversees and participates in the central ethics and sites submissions process, including submission to the Comité central d’éthique de la recherche (CCER).
  • Oversees and participates in the preparation and submission of Health Canada applications (e.g. CTA, CTA-A, CTA-N).
  • Performs regulatory review of essential documents and authorizes shipment of investigational product to clinical sites.
  • Develops regulatory affairs practices improvement initiatives, development of tools, processes and training materials.PROFILE:• Bachelor in science;
  • At least 5 years of experience in regulatory affairs, including pharmacovigilance, in the pharmaceutical, biotechnology and/or CRO industry;
  • Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations. Knowledge of EMEA regulations an asset;
  • Experience with electronic Trial Master Files systems;
  • Staff management experience preferred;
  • Bilingual French and English (excellent oral and written);
  • Ability to organize own work, prioritize different assignments, and work under pressure.

  
  Thanking you in advance for your application. Please note that only selected candidates will be contacted.

  Innovaderm only accepts applicants with a valid Canadian working permit.