specialists in regulatory affairs (Sr.) (Quebec City)

specialists in regulatory affairs (Sr.) (Quebec City)

02 Nov
|
FOP Experts Conseils
|
Quebec City

02 Nov

FOP Experts Conseils

Quebec City

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 cosmetics sector. The mandate is to ensure the regulatory compliance of cosmetic products in Canada and for export and to submit notifications, assess ingredients, validate labelling and claims, and advise teams through ongoing regulatory monitoring. 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

- Submit cosmetic notifications to Health Canada.
- Assess ingredient compliance with the Cosmetic Ingredient Hotlist and the Cosmetic Regulations.
- Review and validate labelling, the INCI list and claims.
- Determine product classification (cosmetic, drug, natural health product).
- Prepare compliance for export markets (FDA/MoCRA, EU Regulation 1223/2009).
- Monitor regulatory developments and communicate new requirements.
- Advise R&D; and marketing on regulatory requirements.
- 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, 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: ISO 22716, Cosmetic Regulations (Health Canada), FDA MoCRA, 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 setting 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

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