Regulatory Affairs Specialist

Laval - Quebec - Canada - LifeSciencesAndHealthCare - Pharmaceutical - Regulatory - AcademicBachelor

We’re hiring a Regulatory Affairs Specialist for our client, a large pharmaceutical company, to join their team. This is a permanent position.

Feel free to contact

Maria Camanag, Account manager

Apply now

About this role

Responsibilities

  • Prepare and compile all type of submissions (NDS, SNDS, ANDS, SANDS, NC, CTA, CTA-A, DINA, PDC, PLA and medical device license applications) to Health Canada in CTD/eCTD format where applicable and as per Health Canada’s Guidelines to obtain marketing authorization for new products (prescription and OTC drugs, natural health products and medical devices) and to maintain as well the conformity and life cycle of currently marketed products (prescribed and OTC drugs, natural health products and medical devices).
  • Plan, manage, and coordinate the preparation, compilation, filing, and approval of high quality regulatory submissions for presentation to Health Canada.
  • Critical assessment of data and documents to identify gaps compared to regulatory requirements.
  • Maintain and ensure regulatory product compliance. Interact, communicate and negotiate with internal and external stakeholders like Health Canada.
  • Prepare and review of responses to Health Canada letters (e.g. Notice of Non-Compliance, Notice of Deficiency, and Clarifaxes) in timely manner
  • Assist in the review and coordinate French translations of Product Monographs and product labelling.
  • Assist in negotiations with Health Canada to ensure prompt regulatory approvals of dossiers under review and in preparation.
  • Maintain current awareness of all regulatory guidelines (Health Canada, ICH, etc…)

About you

Requirements

  • University Degree, B.Sc. or higher in Health Sciences
  • Minimum 4 years of relevant experience in Canadian Pharmaceutical Regulatory Affairs, with recent (2-3 years), solid experience/expertise in managing drug products (Rx, Ethical, DIN-OTC), natural health products (NPN) and medical device licensing (if applicable)
  • Strong working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products (drug products and medical devices)
  • Excellent organizational and communication skills (oral and written)
  • Bilingual (English and French)
  • Ability to prioritize projects, coordinate multiple projects simultaneously and work with tight deadlines
  • Entrepreneurship and focus on customer needs; Good business acumen and sense of urgency; Agility & flexibility; Team player and respect of others
  • Computer Literacy – Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat

What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Publication: PUB225501
  • Location: Laval
  • Market: LifeSciencesAndHealthCare
  • Hours per week: 36.25
  • Branche: Pharmaceutical
  • Education level: AcademicBachelor
  • Area of expertise: Regulatory
  • Closing date: September 22, 2019
Apply now

Feel free to contact

MC

Maria Camanag

Account manager Brunel Canada Toronto

+1 416 244 2402

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