The Associate Manager/Manager of Regulatory Affairs supports the Colgate Oral Care Technology function in the maintenance of existing oral care products and the development of new oral care products for the U.S. market. This support includes managing all regulatory activities necessary to maintain and to grow the U.S. Oral Care franchise. This position is responsible for developing and implementing regulatory strategies for new and existing products regulated under the IND/NDA/ANDA, Medical Device 510(k), OTC Monograph and Cosmetic designations.
This position may also have some responsibility for Personal Care and Home Care products, and may be responsible for other assigned products and projects. The position will serve as a resource to Technology, the U.S. Division and Supply Chain, to ensure alignment with Business, Supply Chain and Technology objectives, programs, strategies, policies and procedures.
Represent and strengthen the expertise in regulatory processes and procedures, using business knowledge to develop actionable regulatory and registration strategies
Support Global Technology innovation platforms for existing and new products.
Communicate the impact of changes in the regulatory environment to the Business and modify strategies accordingly.
Collaborate with internal partners and stakeholders on regulatory procedures, requirements and potential barriers, and work accordingly to incorporate them into the Technology and Business plans and programs.
Establish strong relationships with Corporate and Regional Technology Partners, and with the Divisional stakeholders such as Marketing, Legal, Technical, Supply Chain, Regulatory and Product Safety, to ensure tight alignment and synchronization among Regulatory strategies, product development and business goals
Maintain Regulatory filings and Health Authority communications through electronic and paper records in a timely, accurate and efficient manner.
Provide Regulatory guidance and advice to R&D and other stakeholders.
Stay abreast of current and new U.S. Drug, Device and Cosmetic regulations and guidelines, and ensure adherence throughout product lifecycle.
Ensure productive and collaborative working relationships with the U.S. FDA and other government authorities.
Provide category support on day-to-day regulatory issues, new initiatives and developments.
Represent Colgate to trade associations as assigned, and provide clear updates to stakeholders as necessary.
Bachelor's Degree with a minimum of 10 years of regulatory experience required
Master's degree highly preferred
Working knowledge of U.S. regulatory requirements for INDs and NDAs preferred; experience with eCTD and drug product registration ex-U.S. will be considered
Strong interpersonal and relationship-building abilities
Effective communication and presentation skills
Robust experience with management of multidisciplinary projects to RA department systems and processes
Ability to successfully juggle multiple competing priorities while maintaining attention to detail
Internal Number: 1216
About Colgate Palmolive
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, Speed Stick, Lady Speed Stick, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, elmex, Tom’s of Maine, Sanex, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill’s Science Diet, Hill’s Prescription Diet and Hill’s Ideal Balance.
For more information about Colgate’s global business, visit the Company’s web site at http://www.colgatepalmolive.com. To learn more about Colgate Bright Smiles, Bright Futures® oral health education program, please visit http://www.colgatebsbf.com. To learn more about Hill's and the Hill’s Food, Shelter & Love program please visit http://www.hillspet.com. To learn more about Tom’s of Maine please visit http://www.tomsofmaine.com.