About this role
- Preparing quality regulatory submissions according to Health Canada standards and predefined timelines for drugs, biologics and natural health products. This includes evaluating the available data (chemistry/ manufacturing, clinical and pre-clinical, labelling), preparation of CTD summaries, including Module 1, according to Canadian requirements and preparation of responses to clarification requests according to the Agency’s deadlines.
- Elaborating internal processes for the development of the Regulatory Affairs’ department in collaboration with other departments.
- Supervising the regulatory activities for the licensing and maintenance of pharmaceutical products marketed in Canada and foreign countries.
- 4.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.
- Ensuring liaison with Health Canada for general regulatory matters and product specific issues, including meetings with the Agency.
- Elaborating regulatory strategies to support the company regulatory and business plans.
- Acting as the qualified person for regulatory affairs matters raised internally or by corporate partners.
- Supervision of employees in the Regulatory Affairs’ department.
- B.Sc. in life science discipline or equivalent
- DESS in drug development
- M.Sc. in drug development /regulatory affairs or clinical development an asset
- Knowledge of international regulations an asset
- Minimum of 3-5 years within the pharmaceutical industry; including personnel management
- Strong knowledge of the Canadian regulations and the proven ability to interpret policies and guidelines
- Strong clinical development scientific knowledge
- Excellent communication skills; written and oral French and English
- Strong knowledge of Microsoft Office Suite
- Analytical and Organizational Skills: The candidate must have good analytical skills with a high-level of attention to detail and commitment to accuracy; able to handle multiple projects at a time.
- Negotiation Skills / Teamwork: The candidate must have excellent interpersonal skills and demonstrate flexible and adaptable communications capabilities with partners inside and outside the country, and with regulatory authorities. She/he must be able to effectively function in a fast-paced, people-oriented, team environment.
- Autonomy / Problem-Solving: The candidate must work independently while interacting with various people. She/he must have the ability to identify important issues and to identify solutions in a timely manner.
- Dealing with Ambiguity: The candidate must demonstrate adaptability in situations involving change and the ability to evaluate and properly adapt documents supplied by corporate partners for Canadian regulatory requirements.
What we offer
Why 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.
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.
- Vacancy number: PUB262926
- Location: Montreal
- Market: Life Sciences & Health Care
- hours per week: 40
- Branch: Pharmaceutical
- Education level: Academic Master
- Area of Expertise: Regulatory
- Closing date: Sunday, May 24, 2020
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