Regulatory Affairs Manager - Brossard

Posted on February 14, 2025

Regulatory Affairs Manager – Brossard

Scientific Affairs

Benefits and job description Qualifications and Applicant's profile Avantages

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Benefits and job description

Why join us?

Hybrid position with a flexible schedule;
Regular, full-time position;
Group insurance, including telemedicine and health accounts;
Vacation and paid time off during the holiday season;
Group RSP with employer contribution;
4 sick days per year;
Free indoor parking and office near the REM DIX30 station;
And much more!

Do you have a strong power of influence? Do you have a collaborative approach with management, internal teams and external partners? Do you love guiding, structuring and overseeing the development of regulatory dossiers? This position is for you!

Reporting to the Director of Scientific Affairs, the candidate will play a key strategic role in ensuring the proper management of files while supporting and training the filings team to follow best practices and meet the company’s regulatory objectives.

Main tasks and responsibilities

Develop and lead regulatory strategies and plans for generic, biosimilar and natural health filings with Health Canada;
Supervise, mentor and train the team responsible for submitting bids, providing the necessary information and promoting skills development;
Participate in regulatory due diligence in the context of product acquisitions/dossiers, partnerships or new product launches;
Conduct hires and performance evaluations of staff under his supervision;
Manage the team’s various files and priorities while anticipating resource needs;
Coordinate and optimize internal processes to ensure the efficiency and compliance of regulatory filings;
Collaborate with the various internal departments (Quality, Procurement, Operations and Business Development) as well as with partners and suppliers;
Work closely with your immediate supervisor, ensuring the alignment of strategies and the smooth running of the team;
Perform any other related tasks required by his immediate supervisor or required in the course of his duties.

Qualifications and Applicant's profile

Hold a master’s degree in life sciences (chemistry, biology, biotechnology) or other relevant fields;
Minimum of 10 years of experience in a regulatory affairs management role within the generic pharmaceutical or natural health products industry;
Bilingualism and excellent oral and written communication skills in French and English (to interact with partners and employees outside Quebec and to send submissions to Health Canada);
Good computer skills with Microsoft Office, Adobe and regulatory systems and databases;
Excellent knowledge and mastery of Food and Drug Act and current Canadian regulation. Indepth knowledge of ICH guidelines and specific requirements for generic pharmaceutical products including biosmilars;
Strong communication, collaboration and team management skills;
Ability to structure priorities and implement clear and effective processes;
Ability to work independently and make decisions based on judgment and integrity.

Send us your application to help us provide better care for people!

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