Regulatory Associate

PUB317704

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.

Join the Brunel Family

Asian colleagues having market discussion

Join the Brunel Family

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.

Start applying immediately

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
  • Resume
Apply now

Any questions remaining?

Your consultant, Sabrina Morris is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB317704

Account manager

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

All fresh vacancies in your mailbox?

Sing up for the Brunel job alert

Look at our privacy statement

Other people also looked at