Manager, Regulatory

at  Revlon Canada Inc

At Revlon, we create beauty innovations for everyone that inspire confidence and ignite joy every day.
Breaking beauty boundaries is in our company’s DNA. Since its game-changing launch of the first opaque nail enamel in 1932 (and later, the first long-wear foundation), Revlon has provided consumers with high-quality product innovation, performance, and sophisticated glamour. Elizabeth Arden made waves as a woman-led beauty company in the 1920s. In 1931, Almay became the original hypoallergenic, fragrance-free beauty brand.
Today, Revlon resiliently continues its legacy as a leading global beauty company. Our diverse portfolio—which consists of some of the world’s most iconic brands and product offerings in color cosmetics, skin care, hair color & care, personal care, and fragrances—is sold around the world through prestige, professional, mass, and direct-to-consumer retail channels. These brands include Revlon, Revlon Professional, Elizabeth Arden, Almay, American Crew, CND, Cutex, Mitchum, Sinful Colors, Creme of Nature, Britney Spears, Christina Aguilera, John Varvatos, Juicy Couture, Ed Hardy and more.
We honor our heritage, embrace change, and applaud diversity. We champion our employees and celebrate our consumers.
We are Revlon, together, transforming beauty.
The Regulatory Manager is responsible and accountable for regulatory compliance activities that support new product development and products currently on the market that occur throughout the product lifecycle of OTC drug products, natural health products and cosmetics distributed and sold by Revlon in Canada.
The Regulatory Manager ensures Canadian regulatory requirements are clearly communicated to local and international business units that results in ongoing compliance of formulas, products, labelling, advertising and facilitates appropriate reporting in accordance with Agency requirements and established timelines.

EXPERIENCE:

• 5+ years of experience in Cosmetic, OTC drug and natural health product regulatory affairs.

KNOWLEDGE, SKILLS, & ABILITIES:

• Work independently and viewed at the Regulatory leader for the Canadian operation.
• Knowledge of OTC drug product and natural health product and cosmetic regulations.
• Knowledge of registration requirements.
• Knowledge of post –approval requirements of amendments, notifications and safety reporting.
• Knowledge of claims and advertising requirements.
• Knowledge of requirements that govern licensing of local and foreign sites performing regulated activities.
• Strong attention to details when applying regulatory requirements.
• Strong oral and written communication skills.
• Strong critical analysis skills.
• Strong planning, decision making and problem solving skills.
• Excellent organizational skills.
• Excellent team player that leverages relationships across departments, business functions and regions.
• Strong believer in ability to motivate others by example.
• Strong computer skills and ability to use software (e.g. Microsoft Word, Excel, PPT, SAP).
• Previous direct experience in a Regulatory or Quality role working with Cosmetics/OTC/NHP products in a Canadian operation is highly desirable.

EDUCATION:

• Bachelor of Science Degree in Chemistry, Biology or related science-based field
• Post-graduate certificate in Pharmaceutical, Regulatory Affairs and/or Quality operations desirable

KEY RESPONSIBILITIES:

• Ensure that all products marketed in Canada are supported to assure compliance with Canadian requirements governing Cosmetics, OTCs, and NHP products.
• Collaborates with global regulatory team members and Sales, Marketing, Distribution, Operations, R&D, Quality, Legal, etc to support business activities.
• Primary interface with Canadian Authorities on Regulatory matters, filings, and questions related to Revlon products.
• Monitors Canadian Regulatory activities and identifies emerging regulations and/or changes to Regulations that impact Revlon products. Communicates status and proactively develops plans and gains alignment internally to address any Regulatory change and how it should be managed.
• Represents Revlon at external Trade Association (Cosmetics Alliance Canada).

MAJOR DUTIES:

• Authors product registration applications (DINA for OTC drug products, PLA for natural health products, CNF for cosmetics, Canadian and USA distributor listing application). Ensures filings are completed in a timely manner and within project timelines.
• Maintains product registrations (amendment, notification, and discontinuation).
• Prepare responses to inquiries from Health Canada.
• Reviews and approves product claims, labelling (artwork) and advertising materials.
• Assess compliance of formula ingredients and final formulations in consideration of conditions of use. Proactively alerts business of any issues encountered and how to mitigate.
• Works with Global Regulatory Team on Regulatory related projects and work process improvements.
• Prepare substance dossiers in compliance with Environment and Climate Change Canada requirements.
• Maintain Drug Establishment License and Site License (renewal, amendment, notification).
• Investigate, maintain and trend adverse reactions and quality consumer complaints.
• Prepare Adverse Drug Reaction reports per Health Canada requirements.
• Assist in preparation of Periodic Safety Update Reports.
• Perform regulatory intelligence activities to assess implication and adapt business to changes in regulatory environment. Works closely with Global Regulatory to discuss and align to plans to minimize impact to the business.
• Collaborate with industry organization Cosmetics Alliance Canada and internal stakeholders.
• Subject matter expert that provides guidance to departments within Canadian and international business units.
• Maintain master and executed documents.
• Support process improvement initiatives.
• Authors product registration applications (DINA for OTC drug products, PLA for natural health products, CNF for cosmetics, Canadian and USA distributor listing application). Ensures filings are completed in a timely manner and within project timelines.
• Maintains product registrations (amendment, notification, and discontinuation).
• Reports to the Director, International Regulatory Affairs
• Part of a Global Regulatory team and will have frequent contact with global regulatory team members.
• Collaborate with industry organization (Cosmetics Alliance Canada and other external organizations as appropriate).
• Interactions with various business cross functional groups including Sales, Marketing, Distribution, Operations, R&D, Quality, and Legal.