Senior Regulatory Affairs Manager

3 weeks ago

Markham Ontario, York region, Canada Kelly Science, Engineering, Technology & Telecom Full time

We are currently looking for a Senior Regulatory Affairs Manager for contract role with our pharmaceutical client based out of Thornhill, Ontario. It is a short-term contract with a potential for conversion to perm.


Contract duration: 4months


Role:

Act as the local operational lead for the Regulatory team and focal point for cross-functional stakeholders, supporting the acting Head of Regulatory Affairs for Canada (based in Switzerland), to ensure adequate support and continuity of regulatory activities for the Prescription, Aesthetic and Consumer business unit products including coordination of the preparation and review of regulatory submissions as well as serving on project teams.


Responsibilities:

  • Manage the development of Regulatory Affairs strategies for products for the Prescription, Aesthetic and/or Consumer business units.
  • lead the preparation and review of investigational and marketed product submissions.
  • Develop and ensure execution of regulatory strategies to obtain timely approval of post-approval changes to products approved by Health Canada.
  • Work with Manufacturing, Quality, Medical and Global R&D personnel to enable timely assessment and approval of new products and changes to marketed products.
  • Review and approve labeling, promotional materials and other communications for Prescription, Aesthetic, and Consumer business unit products for compliance with applicable Health Canada regulations.
  • Maintain up-to-date information regarding the Health Canada requirements to ensure timely review and approval of product submissions.
  • Represent the Regulatory Affairs department on assigned project teams.
  • Manage the archiving of regulatory submissions to ensure ease of retrieval.
  • Support audits by Health Canada and/or other regulatory agencies.


Requirements:

  • University degree in a scientific field (e.g., Life Sciences, Chemistry, Biology, Pharmacy, Pharmacology/Toxicology)
  • 7+ years of Regulatory Affairs team leadership and hands-on regulatory technical experience at local affiliate level is required, in the field of class 3 and/or 4 medical devices (such as injectable dermal fillers), and preferably in prescription products (including preparation of Module 1). Additional experience in NHPs, OTCs and cosmetics is an asset.
  • Strong knowledge of Canadian laws and regulations applicable to class 3 and 4 medical devices, biologic products, prescription drugs, as well as OTC drugs, NHPs and cosmetics is required.
  • Hands-on experience reviewing advertising and promotional materials for medical devices and drugs is essential, including experience with PAAB Code of Advertising and Ad Standards Canada.
  • Provide strategic directions to the business, accountable for delivering project goals and aligning functional strategies with business needs.
  • Ability to navigate a complex landscape of stakeholders in a matrix environment.
  • Experience with Health Canada interactions regarding new product development, leading pre-submission meetings and post-approval changes.
  • Excellent written and oral communication and willingness to share knowledge learned.
  • Excellent organization skills including the ability to prioritize and multi-task.
  • Effective influencing, strategic and negotiating skills.

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