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Regulatory Affairs Associate

3 months ago

Markham, Canada Kelly Science, Engineering, Technology & Telecom Full time

We are currently recruiting for a contract position for our pharmaceutical client for an ONSITE role.

Location: Thornhill (Markham)- Hybrid/Onsite

Duration: 6 months contract with potential for extension

Regulatory Affairs Associate

Role:

Responsible for regulatory activities in support of assigned Aesthetic and/or Consumer business unit products including coordination of the preparation and review of regulatory submissions as well as serving on project teams. Primary immediate focus of the role would be on medical device class 3 or 4 and cosmetic brands.

Responsibilities:

  • Coordinates the preparation and review of regulatory submissions for Aesthetic and/or Consumer business unit products.
  • Responsible for preparation and submission of cosmetic, medical device, natural health product (NHP) and/or non- prescription drug applications to obtain product license for Canada.
  • Works with manufacturing, Quality Assurance, Graphics, Supply Chain and Marketing to enable timely assessment and approval of new products and changes to marketed products as needed.
  • Reviews and approves labeling, promotional materials (HCP and consumer facing) and other communications for Aesthetic and/or Consumer business unit products for compliance with applicable Health Canada Regulations.
  • Maintains up-to-date information regarding the Health Canada requirements to ensure timely review and approval of product submissions.
  • Represents the Regulatory Affairs department on assigned project teams.
  • Manages the archiving of regulatory submissions to ensure ease of retrieval.
  • Supports audits by Health Canada and/or other regulatory agencies.
  • Other duties may be assigned.

Requirements:

  • Bachelor’s degree required in science or related field.
  • Overall 5 years of thorough regulatory affairs experience is desired, with minimum 2-3 years of Canadian Regulatory Affairs experience in pharmaceuticals and/or medical device & cosmetics.
  • Candidates with experience with medical device class 3 or 4 and cosmetic brands will be preferred. However, some regulatory submission experience (ITA and Lifecycle Management) with medical devices would also be good.
  • Strong knowledge of review & approval of promotional materials and artwork.
  • Working knowledge of Health Canada laws and regulations of OTC, NHPs and cosmetics is required.
  • Experience with Plain Language Labelling for OTC and NHP is an asset.
  • Must be proficient with Microsoft Word and other common software tools.
  • Must be experienced with, or capable of learning how to use, electronic review systems.
  • Must have the ability to handle confidential information and materials in an appropriate manner, and in accordance to organizational policy, proper business practice, and/or appropriate external regulation/governance.
  • Excellent communication (verbal/written), interpersonal, and organizational/ time management skills are required.
  • A high level of integrity while working under pressure is required.
  • Ability to function effectively with minimum supervision is required.
  • Employee must be able to multi-task and prioritize
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