Regulatory Affairs Specialist

6 days ago

Markham, Ontario, Canada Kenvue Full time
Regulatory Affairs Intern

Kenvue is seeking a highly motivated and detail-oriented Regulatory Affairs Intern to join our team. As a Regulatory Affairs Intern, you will be responsible for preparing submissions, responding to regulatory body queries, and performing assessments to determine regulatory requirements for new projects.

Key Responsibilities:
  • Prepare submissions, including NHP PLAs, DIN submissions, SNDSs, NCs, Level III notifications, Class II medical device applications/amendments, and cosmetic notifications forms.
  • Prepare responses to regulatory body queries and file various annual renewal packages to Health Canada.
  • Perform assessments to determine regulatory requirements for new projects and review and approve packaging artwork and/or advertising materials.
  • Complete environmental ingredient surveys under CEPA and assist in audit preparation and provision of documents to auditors.
  • Respond to requests for regulatory information from our safety organization to support preparation of aggregate safety reports.
  • Monitor departmental mailbox and triage Health Canada and other correspondence, and monitor and track communications and commitments to Health Canada.
  • Maintain various regulatory databases/trackers.
Qualifications:
  • Enrolled in a post-graduate Regulatory Affairs Certification Program (e.g. Seneca or Humber College).
  • Undergraduate Science Degree.
  • Excellent communication (written and verbal) and strong interpersonal skills.
  • Good problem-solving and analytical skills.
  • Self-driven, ability to work independently.
  • Results-driven, excellent attention to detail.
  • Strong project management skills and ability to manage multiple priorities.
  • Strong office software skills.
What's in it for you:
  • Learning & Development Opportunities.
  • Employee Resource Groups.

The anticipated weekly base pay for this position will be based on candidate's program year, discipline, and degree/experience. Co-Ops/Interns may be eligible to participate in Company employee benefit programs such as medical insurance, sick time, and holiday pay in accordance with the terms of the applicable plans.

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