Regulatory Associate

PUB317704

medical device pharmaceutical food industry

About this job

  • Industry: Pharmaceutical
  • Area of expertise: Regulatory
  • Location: Montreal

What is required?

  • Hours per week: 40
  • Education level: Academic Bachelor
  • Closing date: Friday, 8 October 2021

About this role

About this role

Reporting to the Director of Regulatory Affairs, the associate will assume responsibilities within the Scientific Affairs department to ensure the timely approval and regulatory maintenance of pharmaceutical products in Canada and foreign countries, in collaboration with corporate partners. The ideal candidate is highly organized, has flexible and adaptable communications capabilities and demonstrate good problem solving skills.
Has experience with CMC, Clinical, and Pre-clinical drug submissions or drugs, biologics and natural health products.

Responsibilities• Participate in the preparation of quality regulatory submissions to Health Canada according to predefined timelines. This includes evaluating the data (chemistry/ manufacturing, clinical and pre-clinical), preparation of CTD summaries, as well as project coordination with consultant, for drugs, biologics and natural health products.
• Support in the preparation of technical documents/summaries required for initial or any type of post-approval regulatory submissions with Agency.• Responsible for Drug Notification forms and any Administrative submission (ex: DIN transfers, Annual reports, etc.).
• Evaluates regulatory information and determines acceptability of data and other product-related documentation presented in support of product registration. • Review technical and clinical documentation and may recommend changes in labeling, manufacturing, marketing to maintain regulatory compliance.
• Support in the preparation of responses to Regulatory Agencies with all necessary information. • Participate in the elaboration and/or update and/or review of product labelling.
• Liaise with commercial partners involved in the licensing of pharmaceutical products in foreign countries.• Maintains databases and archives.
• Assist with the preparation of departmental standard operating procedures (SOPs).

Requirements

Requirements

• B.Sc. in life science discipline or equivalent• DESS in drug development
• M.Sc. in drug development (asset) • Strong scientific knowledge
• Strong knowledge of the Canadian regulations and good ability to interpret policies and guidelines• Excellent communication skills, written and oral in English and French 1-3 years within the pharmaceutical industry, including managerial responsibilities
• Knowledge of international regulations• Proficiency in Spanish (Asset)
• Good knowledge of Microsoft Office Suite • Project management tools

Benefits

Benefits

What We OfferWhy 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 Brunel

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About Brunel

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.

How to apply

How to apply

If you meet the above requirements and would like to be considered for this role, please submit your interest using the ‘Apply’ button. Applying is quick and easy – just make sure you have the following documents ready to go:

  • Resume
  • Cover Letter (optional)
Apply now

Do you have questions?

If you have questions or would like to discuss the details of this role, please contact Sabrina Morris via the details below, quoting publication number:
PUB317704

Account manager

Sabrina Morris
Brunel Canada - Calgary
s.morris@brunel.net

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