Director Regulatory Affairs

Montreal - Quebec - Canada - Life Sciences & Health Care - Pharmaceutical - Regulatory - Academic Bachelor

Reporting to the Senior Director, Scientific Affairs, this full-time position will assume responsibilities within the Scientific Affairs department to ensure the timely approval and regulatory maintenance of pharmaceutical products in Canada in collaboration with corporate partners and with a focus on clinical efficacy and safety. The ideal candidate has demonstrated good problem-solving skills and has experience reviewing/editing Common Technical Documents (CTDs) scientific summaries supporting Canadian New Drug Submissions, as well as experience communicating with Health Canada regarding regulatory dossiers.

Feel free to contact

Diana Grodowski, Account manager

Apply now

About this role

Responsibilities

  • Overall responsibility for the quality and timely preparation of Canadian regulatory dossiers, as well as responses to information requests issued by Health Canada for drugs, biologics, and Natural Health Products. This includes responsibility for ensuring data is compliant with Canadian regulations and developing strategic approaches to present the dossier according to Health Canada's guidelines and requirements. Participation in the preparation of the regulatory dossiers (NDS, SNDS, NC) will be determined based on the department priorities, including:
  • the coordination and supervision of the preparation of the various CTD modules for inclusion in Canadian regulatory dossiers and/or;
  • the review/edit of specific CTD modules related to clinical and nonclinical data and/or;
  • the preparation and/or review of Product Monographs;
  • Ensuring efficient communication with internal and corporate partners for the preparation of regulatory dossiers, as well as during Health Canada review of the dossiers;
  • Overall responsibility for efficient and strategic communication with Health Canada for general regulatory matters and product specific issues, including meetings with the agency;
  • Critical assessment of clinical and nonclinical development data related to in-licensing and due diligence activities;
  • Planning and coordinating the various activities within the regulatory department according to corporate priorities;
  • Overall responsibility for post-approval clinical and safety commitments, compliance of Product Monographs, review and internal approval of Annual Safety Reports and Risk Management Plans;
  • Collaboration with Quality Assurance and Marketing for strategic product launches;
  • Implementation and improvement of internal processes within the Regulatory Affairs department, in collaboration with other Knight departments;
  • Providing regulatory support for projects related to the transfer of product manufacturing sites, as necessary.
  • Supervision of employees in the Regulatory Affairs department;

About you

Qualifications/Job Requirements

  • B.Sc. in life science discipline or equivalent;
  • Minimum of 8 years within regulatory affairs in a pharmaceutical company, including experience in the preparation of CTD modules for New Drug Submission;
  • Strong knowledge of Canadian regulations and the proven ability to interpret policies and guidelines;
  • Strong clinical development scientific knowledge;
  • Excellent communication skills; written and oral English;
  • Strong knowledge of Microsoft Office Suite.

Assets

  • DESS or M.Sc. in drug development /regulatory affairs or clinical development;
  • Knowledge of risk management or pharmacovigilence.

What we offer

What we offerBrunel Life Sciences provides global staffing, recruitment, and contracting solutions for Life Sciences, Pharmaceutical, Biotechnology and Healthcare organizations. Brunel Life Sciences plays a vital part of the Brunel International Group, with over 100 offices in 40 countries and approximately 13,000 employees around the globe

What the client offers

  • Competitive salary and bonus plan
  • Employee stock option plan
  • Employee share purchase plan
  • Flexible group insurance plan
  • Registered retirement savings plan

Summary

  • Vacancy number: PUB205480
  • Location: Montreal
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branche: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of Expertise: Regulatory
  • Closing date: Monday, May 13, 2019
Apply now

Feel free to contact

DG

Diana Grodowski

Account manager Brunel Canada Toronto

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