Regulatory Affairs Associate

4 months ago

PointeClaire, Canada Delon Laboratories Full time

**Our Business**:
Delon Laboratories is a cosmetic and pharmaceutical manufacturer in the West Island of Montreal.

**Job Purpose**
The Regulatory Affairs Associate acts as a liaison between Delon and all governmental institutions, both Canadian and international.

**Duties & Responsibilities**
- **Governmental Liaison**: License renewal, license management, and document retrieval, annual drug review;
- **Registration**: Files registration of products with governmental regulatory bodies, both Canadian and international, for drug and cosmetic products;
- **Artwork approval**: Artwork approval for drug and cosmetic products;
- **Knowledge of Regulation**: Knowledge source for regulations of Canada, USA, EU, and others;
- **Certificate of Free Sale Acquisition**: Contact the CCTFA or other provider of CSF to obtain a certificate of free sale necessary for export to other countries. Manages label submission and coordination of license requisition;
- **SOP Drafting**: Write SOP’s for RA Department as well as other departments at Delon. Verify and review current SOPs for any changes or updates;
- **MSDS writing**: Create MSDS for all products of Delon, and update old MSDS;
- **Client Surveys**: Manage client interactions for surveys that involve regulation and governmental initiation. Coordinate with clients for submission of information;
- **Product Review**: Ensure that product formulas comply with applicable regulations, taking into account country specific regulatory rules regarding cosmetic/drug components;
- **Pharmacovigilance System**:To follow the pharmacovigilance procedures regarding adverse reactions and serious adverse reactions for marketed health products in compliance with Good Pharmacovigilance practices.

**Qualifications**
- Science background or similar domain
- 1-3 years of experience working with Health Canada, FDA, and EU regulations related to drug and cosmetic products
- Strong research skills & ability to accurately interpret information
- Strong writing skills
- Work experience in pharma or cosmetic manufacturing facility is an asset
- Bilingualism (English and French) is an asset
- Ability to work autonomously and in a team

**Job Types**: Full-time, Permanent

**Benefits**:

- Dental care
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Store discount

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Pointe-Claire, QC H9R 1E2: reliably commute or plan to relocate before starting work (required)

Application question(s):

- Are you legally authorized to work in Canada?

Work Location: In person

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