Job Description

No Relocation Assistance Offered
# 153984 - Toronto, Ontario, Canada

Regulatory Affairs Associate - Contract

Role Summary:

The primary role of the Regulatory Affairs Associate is to help ensure regulatory compliance, and to support the maintenance of the Company\'s marketed products throughout the product lifecycle. This support includes performing regulatory activities necessary to maintain and to grow the business.

With oversight of the Regulatory Manager, this position has responsibility for developing and implementing regulatory projects, planning for the launch of new and existing Oral Care NHP and non-prescription drug products, and other projects as assigned. The Associate helps to identify regulatory classification and make recommendations regarding the regulatory pathway to market for Oral Care products. They independently review product ingredients, formulations, technical information, labeling/advertising claims and artwork to facilitate market authorizations and ongoing compliance with regulatory requirements. With modest supervision from the Manager, provides regulatory information, guidance and intelligence to cross-functional partners to ensure timely market introduction and continuance in accordance with applicable regulations.

Responsibilities:

Support Licensing and Launching of New Products: Help manage and prepare submissions for timely regulatory approvals for new non-prescription and natural health product drugs, line extensions and formula/packaging updates. Evaluate formula, ingredients, packaging and manufacturing changes to help determine drug submission types and documentation support requirements. Utilize regulatory knowledge to help provide input to business and strategic technical decisions. Act as a resource for cross-functional partners for questions related to regulations and assist in tasks such as regulatory assessments for oral care drug products.

Ensure Regulatory Compliance: Assist in development of regulatory project plans to ensure successful implementation of new regulatory requirements. Help assure regulatory compliance of marketed oral care products in accordance with applicable regulations/guidances/market authorizations, including the documentation and filing of any changes, and review and approval of recipes, label copy/promotional materials and artwork.

Monitor Regulatory Environment: Monitor external developments that may impact the business, and in conjunction with business partners and Regulatory Manager, help evaluate impact and create compliance plans. Provide regulatory or technical information and guidance on product regulations or regulatory initiatives to internal customers (i.e. Marketing, Research & Development, Quality Assurance, Consumer Affairs, etc.).

Contribute to the overall operating efficiency of the department by: Work to help continuously improve established regulatory processes and provide input to policies to reflect standard practices. Comply with all local and corporate SOPs. Assure records are accurate and up-to-date to track regulatory activities such as submissions and renewals.

Job Requirements:

University degree required; degree in Life sciences or Regulatory Affairs Certification is preferred (e.g., chemistry, pharmacy, biology)

2+ years experience in Regulatory Affairs, including regulatory approval and submission activities for monograph and non-monograph DIN and NHP drugs.

Detail oriented. Good communication skills (interpersonal, writing and oral).

Project management and organizational skills.

Good knowledge of Google tools for word processing, spreadsheets and presentations

Strong interpersonal and relationship-building abilities

Sound decision-making

Ability to successfully juggle multiple competing priorities while maintaining attention to detail

Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.

Are you interested in working for Colgate-Palmolive? You can apply online and attach all relevant documents such as a cover letter and resume or CV. Applications received by e-mail are not considered in the selection process. Become part of our team. We look forward to your application.

Colgate-Palmolive is a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognized brand names as Colgate, Palmolive, elmex, Tom\'s of Maine, Sorriso, Speed Stick, Lady Speed Stick, Softsoap, Irish Spring, Protex, Sanex, Elta MD, PCA Skin, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill\'s Science Diet and Hill\'s Prescription Diet.

For more information about Colgate\'s global business, visit the Company\'s web site at . To learn more about Colgate Bright Smiles, Bright Futures\xc2\xae oral health education program, please visit . To learn more about Hill\'s and the Hill\'s Food, Shelter & Love program please visit . To learn more about Tom\'s of Maine please visit .

Reasonable accommodation during the application process is available for persons with disabilities. Please contact Application_Accommodation@colpal.com with the subject "Accommodation Request" should you require accommodation.

Colgate-Palmolive