POSITION DESCRIPTION

FOP CONSULTANTS is looking for specialists in regulatory affairs at the senior level motivated to deliver on mandates for its clients in the pharmaceutical and biopharmaceutical sector. The mandate is to define regulatory strategies and prepare eCTD submission filings for Health Canada and the FDA and to manage post-approval changes, review labelling and maintain marketing authorizations through ongoing regulatory intelligence. The senior scope is further to define the regulatory strategy and the approval timeline and to mentor intermediate consultants and review their submissions.

KEY RESPONSIBILITIES

- Prepare and submit regulatory filings (NDS, ANDS, IND, NDA) in eCTD format.
- Define regulatory strategies for development and market authorization.
- Assess the regulatory impact of changes and manage post-approval changes.
- Serve as liaison with Health Canada, the FDA and other agencies.
- Review labelling, monographs and promotional material.
- Provide regulatory intelligence and communicate current requirements.
- Maintain marketing authorizations, establishment licences and DINs.
- Define the regulatory strategy and the approval timeline.
- Mentor intermediate consultants and review their submissions.
- Lead exchanges with Health Canada, the FDA and foreign authorities

CANDIDATE PROFILE

- Bachelor's or master's degree in science (chemistry, biochemistry, biology, pharmaceutical, pharmacovigilance, drug development,



etc.), or any other related discipline.
- Minimum ten (10) years of industry experience.
- Eight (08) to fifteen (15) years of experience as a Specialist in Regulatory Affairs.
- Sector standards: GMP (Health Canada), FDA 21 CFR 210-211, ICH Q7 to Q10, GAMP 5, ISO 9001.
- Tools and systems: MS Office suite, Veeva Vault RIM, eCTD, regulatory databases.
- Hold one of the following certifications: RAC (RAPS), regulatory affairs certification.
- The following are considered assets: ASQ CQA, PMP, intellectual property training.
- Experience in Canadian public or private organizations.
- Language: French and English

WORK MODE

- Remote, Hybrid, On-site

WHAT WE OFFER

At FOP CONSULTANTS, we invest in the success and well-being of our experts. By joining our team, you benefit from an environment designed to support your performance and respect your work-life balance, including:

- Competitive compensation that reflects your expertise;
- Complete protection through our group insurance plans;
- Professional liability insurance so you can practise with confidence;
- Remote-work flexibility, based on client needs;
- 3 weeks of vacation to recharge;
- 3 paid sick days, to take care of yourself;
- A monthly allowance for your transportation costs;
- Real opportunities for advancement within the organization;
- Ongoing access to training to grow your skills.

📌 specialists in regulatory affairs (Sr.) (Quebec City)
🏢 FOP Experts Conseils
📍 Quebec City