regulatory affairs associate

Posted on December 11, 2024 by Employer details Delon Laboratories

Job details

*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): * Which do you prefer? A) Work from Office. B) Work from Home. C) Hybrid Education: * Bachelor's Degree (preferred) Work Location: In person