Regulatory Affairs Manager

PUB308935

About this role

About this role

We’re hiring a Bilingual Regulatory Manager for a highly successful Pharmaceutical client located in Montreal Quebec . This role is currently remote post covid will be in office.

The Manager will assume responsibilities within the Regulatory Affairs department to ensure the timely approval and regulatory maintenance of pharmaceutical products in Canada and at the international level, in collaboration with corporate partners.
The ideal candidate is highly organized, has flexible and adaptable communications capabilities, demonstrate good problem solving skills and can adapt to changing priorities.
This role reports to the Director of Regulatory Affairs

Responsibilities
1.Preparing quality regulatory submissions according to Health Canada standards and predefined timelines for drugs, biologics and natural health products.
This includes:
i. Evaluating the available data (chemistry/ manufacturing, clinical and pre-clinical, labelling);
ii. Preparation of CTD summaries, including Module 1, according to Canadian requirements;
iii. Preparation of responses to clarification requests according to the Agency’s deadlines.
2. Building regulatory strategies to support the company regulatory and business plans. Develops project timelines, develops strategic goals with staff, and provides guidance as needed for completion of tasks. Maintains effective communication with partners and project team members. Reports progress, challenges, issues, actions and support required.
3.Elaborating internal processes for the development of the Regulatory Affairs’ department in collaboration with other Knight departments.
4. Supervising the regulatory activities for the licensing and maintenance of pharmaceutical products marketed in Canada and foreign countries.
5. Ensuring liaison and coordination with corporate partners and consultants for the preparation of quality regulatory dossiers, as well as during Health Canada review of the dossiers.
6. Ensuring liaison with Health Canada for general regulatory matters and product specific issues, including meetings with the Agency.
7. Acting as the qualified person for regulatory affairs matters raised internally or by corporate partners.
8. Supervision of employees in the Regulatory Affairs’ department.
9. Providing clear directives to achieve a balance between regulatory concerns, marketing objectives, compliance, time to market, and regulatory costs.

Requirements

Requirements

Qualifications:

  • Bilingual (French/English)
  • Bachelors degree ideally in life science
  • DESS in drug development
  • 3+ years supporting regulatory submissions within HC and international
  • Managerial experience
  • Seasoned knowledge of Canadian regulatory and good ability to interpret policies and guidelines
  • Advanced user of Microsoft office suite products

Benefits

Benefits

What we offer
Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 44 countries. Advancing your career takes time and effort – let us match you to your ideal position.

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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

Start applying immediately

Start applying immediately

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  • Motivation Letter (optional)
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Any questions remaining?

Your consultant, Diana Grodowski is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB308935

Account manager

Diana Grodowski
Brunel Canada - Toronto
d.grodowski@brunel.net

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