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canada Senior Regulatory Affairs Associate

  • Location
    (CANADA) and Montreal
  • Job Reference
    12011
  • Functional Area/Experience
    Health and Life Sciences / 3 Years

Job Description & Qualifications

Duchesnay Inc., located in Blainville, 20 kilometres north of Montreal, is a specialty pharmaceutical company with a long-standing commitment to women’s health. In addition to filling the void in terms of scientific research, education and information and developing pharmacological solutions that are safe for use during pregnancy and breastfeeding, Duchesnay is equally committed to ensuring women’s health and improving their quality of life at every life stage. Thus, Duchesnay has broadened its portfolio of products to offer safe and effective therapeutic options that meet the health and quality of life needs of women and their family members at different stages of their lives. The company offers state of the art facilities, a safe and stimulating work environment and a pleasant atmosphere.

Medunik Canada, a Duchesnay’s sister company located in Blainville, is a a unique company dedicated to improving the health and quality of life of Canadians with rare diseases by bringing orphan drugs to Canada.

Role and Responsibilities:

The successful candidate will report to the Regulatory Affairs Director. The responsibilities will be to:

  • In collaboration with internal team members and external regulatory consultants, plan, organize, file and track various types of regulatory submissions ( NDS, NDA, ANDA, DINA, CTA, IND, Medical Devices) and reports with various agencies (Health Canada, FDA, EMA)
  • Prepare submissions for changes to approved products (SNDS, NC, PAS, CBE) for regulatory agencies as per required regulatory timelines
  • Ensure compliance with applicable regulations and guidelines
  • Search, analyze, interpret and implement international regulations, guidelines and policies as they pertain to Duchesnay products
  • Maintain and classify guidance documents and guidelines
  • Review/edit promotional materials and product labelling components for compliance with regulations
  • Submit and update product monographs for pharmaceutical compendia
  • Liaise with internal QA/QC department and external partners to consolidate relevant technical documents for product dossiers
  • Comply with quality requirements (including ISO 13485 on medical devices);
  • Participate in the development and implementation of standard operating procedures
  • Provide support for health authority inspections
  • Review research and clinical documents such as study protocols and safety reports for regulatory content

Qualifications:

  • Bachelor Degree in one of the Life Sciences fields or in Chemistry
  • At least 3 years of experience in Regulatory Affairs submission preparation and familiarity with TPD/FDA/ICH guidelines (familiarity with European/international regulations an asset)


Job Skills/Competencies Required

  • Excellent communication, documentation, organizational and interpersonal skills
  • Analytical and pre-emptive problem-solving skills
  • Ability to work independently or as part of team toward deadlines
  • Ability to adapt and be flexible
  • Bilingual (French/English, both written and spoken)
  • eCTD submission experience (familiarity with Lorenz docuBridge® a strong asset)
  • Proficient Microsoft Office and internet skills

We offer a competitive salary and a full range of fringe benefits. This is a permanent position and available immediatly.

If you are interested and have the required qualifications, please submit your resume by e-mail

Apply now