Specialist, Regulatory Affairs
Located in Montreal, Quebec, the Canadian company Marcelle Group is a leader in the cosmetics industry. With the highest standards of quality and excellence, Marcelle Group develops, manufactures, and distributes care and makeup products and accessories with a portfolio of four brands: Marcelle, Lise Watier, Annabelle and CW Beggs and Sons.
At Marcelle Group we believe in Passion, Quality, Innovation, Collaboration, Integrity and Respect. We are looking for professionals who will exemplify these values and bring energy and commitment to results.
Join a company with more than 400 employees in the cosmetics field and play a key role in the organization.
Reporting to the Regulatory Affairs Manager, the Specialist, Regulatory Affairs must have the ability to manage multiple projects at the same time as well as strong oral and written communication and interpersonal skills.
As a member of the Regulatory Affairs team, you participate in the regulatory submission process (Canada, US and Europe) and support international cosmetic registration cases. You also assist product development teams to bring your regulatory expertise.
- Workplace: 5600 Chemin Côte-de-Liesse, Montreal, Quebec.
- Growing business.
- A formidable and dynamic team of professionals.
- Benefits: competitive base salary and generous benefits package (including flexible hours, insurance, and holidays during the holidays).
- Discounts offered to employees on all Groupe Marcelle products.
WHAT YOU ARE GOING TO DO:
- Prepare, draft, assemble, review, submit and archive regulatory submissions to Canadian, US and European authorities (Health Canada, FDA, etc.) for the marketing of cosmetic products and as well as the discontinuation of said products.
- Work together with the R & D and Marketing teams in implementing regulatory strategies for all stages of product development and modification and share your knowledge of regulatory processes.
- Evaluate the proposed product changes and determine their impact on the regulatory status of cosmetic products.
- Review promotional and advertising materials as well as product labeling and printed materials to ensure compliance with Canadian, US and European regulations.
- Ensure the transcription of the lists of INCI names for the various sales media (primary, secondary packaging etc.) in addition to completing and updating all tables, internal databases and reference files (list of ingredients, INCI list, allergens, IFRA, official name, DMF, DIN / NPN, etc.).
- Develop a DIP for each product marketed.
- Have a role of advising internal teams on regulatory issues.
- Manage and maintain the pharmacovigilance process.
- Keep the pharmacovigilance procedure up to date according to the GUI-0102 in force.
- Process EID declarations in accordance with the applicable procedure in force.
- Evaluate EID data in a timely manner, including record keeping.
- Have RID claims assessed by a qualified health care professional, including the RID review process.
- Carry out documentary research, annual summary reports, summary reports relating to an area of concern in a timely manner.
- Give the annual BPV training.
- Report all serious (Canada and foreign) and unexpected (Canada) AEs to Health Canada.
- Provide Health Canada with the required information in the event of serious and / or unforeseen adverse reactions or when other requests are requested by HC, in a timely manner.
- Inform Health Canada of adverse drug reactions (ADRs) and any unusual inability of a new drug to produce the intended effect.
- Keep contractual agreements related to pharmacovigilance up to date.
- Cosmeto-vigilance related to export.
WE WOULD LIKE TO MEET YOU IF YOU HAVE:
- Bachelor of Science degree or related field.
- 3 to 5 years of experience in the cosmetic and / or pharmaceutical field.
- Excellent oral and written communication skills.
AND YOU ARE:
- Known for your interpersonal skills, your resourcefulness, and your collaborative approach in gathering information and intelligence.
- Highly autonomous, organized and detail-oriented person.
- Recognized for your great ability to readjust your priorities and demonstrate versatility and flexibility.
- Stimulated by the mobilization of development teams towards regulatory strategies.
- Bilingual: French and English.
The task and responsibilities listed above are summaries and indicatives.
We invite interested individuals to use our online recruitment module by submitting an application to https://www.groupemarcelle.com/view-jobs/ or by sending us your resume in complete confidentiality to: RH@groupemarcelle.com.
DIVERSITY AND INCLUSION
Groupe Marcelle wants to offer equal employment opportunities to all. It invites women, members of visible and ethnic minorities, Aboriginals and persons with disabilities to apply. Groupe Marcelle is also committed to pursuing the integration of diversity and making it a source of enrichment and pride for all its employees.
The use of the masculine gender in this document refers to both men and women.
Groupe Marcelle thanks all candidates for their interest; however only those selected to continue in the process will be contacted.