Regulatory Affairs Specialist Americas, Global Skin Health (Fixed 2 year)

No Relocation Assistance Offered
# 155619 - Piscataway, New Jersey, United States

Who We Are
Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries and territories under brands such as Colgate, Palmolive, elmex, hello, meridol, Sorriso, Tom’s of Maine, EltaMD, Filorga, Irish Spring, PCA SKIN, Protex, Sanex, Softsoap, Speed Stick, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill’s Pet Nutrition.

We are recognized for our leadership and innovation in promoting sustainability and community wellbeing, including our achievements in decreasing plastic waste and promoting recyclability, saving water, conserving natural resources and improving children’s oral health.

If you want to work for a company that lives by their values, then give your career a reason to smile and join our global team!
 

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 moderate supervision by the Regulatory Manager, this position is responsible to perform regulatory activities to support product development and registration projects, including the launch of new and existing skin care cosmetic and drug products and other projects as assigned. The Associate will research product ingredients, review formulations, approve label ingredient statements, review and approve artwork to ensure product and ingredient claims are compliant with applicable regulations. S/he will support the Regulatory Operations team to assemble the product files for the country registrations in Americas region and reporting/listing to federal and state governments to help assure ongoing compliance with regulatory requirements. S/he will also follow up the Regulatory landscape (OTC Monographs/Administrative Orders, MOCRA, federal/state regulations on ingredients of concern, etc) for the SkinCare/Skin Health products in the Americas region and may also draft procedures accordingly.

Responsibilities:

• Regulatory Project Coordination Coordinate new product Launch / Relaunch projects working in strong partnership with the cross functional teams (R&D, Marketing, Supply Chain, Legal, etc) to explain and guide them through the applicable regulatory requirements.  Work in close collaboration with the rest of the regulatory team in the other regions to accelerate the product launches globally.
• Support Product Reporting, Notification and Licensing Guide Regulatory Operations team with the required documents to register/notify the products in the Americas region. Coordinate / work with the Regulatory Operations team for submissions to enable timely regulatory approvals for new cosmetics and non-prescription drugs, line extensions and formula/packaging updates. Support Reg ops team to obtain and assemble documentation and complete required forms. Assure records are accurate and up-to-date to track regulatory activities such as submissions and renewals.
• Ensure Regulatory Compliance:  Help assure regulatory compliance of marketed skin care products in accordance with applicable regulations/guidances/market authorizations, including the documentation and filing of any changes. Perform routine regulatory activities such as the review and approval of raw materials, formulas, ingredient lists and artwork as assigned. With minimum supervision, perform routine pre-established tasks such as Regulatory Assessments for new and relaunch formula/ product types. Generate a compliance report for Americas and review reports against jurisdictional compliance.
•  Assure good documentation practices including recordkeeping: Maintain accurate up-to-date records to track regulatory activities such as submissions, renewals and authority contacts/demands.  Help to improve and to document processes to reflect standard practices. Comply with all local and corporate SOPs. Draft procedures when necessary.

Required Education and Experience:

• University Degree in a scientific field required (B.Sc., etc.)
•  3+ years experience in North America regulatory affairs, with focus on cosmetics, cosmetic-drugs, NHPs and/or DIN drugs, sunscreens
• Understanding of Global Regulatory Landscape

Preferred Education and Experience:

•  Regulatory Affairs Certification is preferred but not required
•  Good knowledge of Google tools for word processing, spreadsheets and presentations
•  Project management and organizational skills
•  Detail oriented. Good communication s