Colgate Palmolive Associate Director - Regulatory Affairs - North America in Piscataway, New Jersey
Relocation Assistance Offered Within Region
# 108793 - Piscataway, New Jersey, United States
Do you want to come to work with a smile and leave with one as well? In between those smiles, your day consists of working in a global organization, continually learning and collaborating, having stimulating discussions, and making impactful contributions!
If this is how you see your career, Colgate is the place to be!
Our diligent household brands, dedicated employees, and sustainability commitments make us a company passionate about building a future to smile about for our employees, consumers, and surrounding communities. The pride in our brand fuels a workplace that encourages creative thinking, champions experimentation, and promotes authenticity which has contributed to our enduring success.
If you want to work for a company that lives by their values, then give your career a reason to smile...every single day.
In today’s dynamic environment, it is an exciting time to be a part of the research and technology team at Colgate. Our highly technical and innovative team is dedicated to driving growth for Colgate Palmolive in this ever-changing landscape.
What role will you play as a member of the Colgate’s Research & Development team?
As the Associate Director North America Regulatory Affairs, you will be responsible to support the Colgate Oral Care and Toothbrush Technology functions in the maintenance of existing products and the development of new products for the U.S. and Canadian markets. This includes providing strategic regulatory mentorship and leading all regulatory activities vital to maintain and to grow the North American professional Oral Care franchise.
The Associate Director of Regulatory Affairs applies regulatory intelligence and expertise to effect innovative regulatory pathways and solutions for sophisticated regulatory requirements to support Company’s products with IND/NDA/ANDA/DIN and Medical Device designations.
This position also has responsibility for other new drug submissions, such as surface disinfectants and antiseptic skin cleansers. The position will serve as a resource to Technology, the North America Division and Supply Chain to ensure alignment with shared objectives, programs, strategies, policies and procedures. This position has one direct report in the United States and works closely with Canadian Regulatory to resolve whether regulator approval is required and to align on submission strategy.
Who are you?
You are a leader:
Serves as liaison and chief correspondent to USFDA and Health Canada on all drug and device pre-submission meetings and lifecycle submissions.
Subject matter authority in regulatory processes and procedures for drugs and devices, including IND/NDA/ANDA/NDS/DIN/510k pathways.
Uses business and regulatory knowledge to provide mentorship and support to Global Technology partners.
Leads cross-functional teams to build and implement intelligent regulatory strategies throughout the product lifecycle.
Plans and supervises regulatory submissions and all post-marketing commitments to FDA and Health Canada to assure quality, compliance and timeliness.
Leads planning and execution of device submissions to USFDA, including Medical Device 510K Notifications, de novo Submissions, Pre-Market Approvals (PMAs) as needed.
Monitors and interprets changes to U.S., Canadian, ICH and ISO guidances and regulations governing product development, testing, manufacture, labeling, advertising and promotion.
Reviews manufacturing/quality change controls to assess the scope/impact of the change(s) and to recommend the appropriate regulatory pathway to implement the change(s).
Bachelor's Degree and minimum 15 + years of experience of confirmed ability showing progression through roles of growing responsibility.
Experience with device or drug applications to the U.S. FDA
Direct, recent experience in the new drug approval process and handling face-to-face meetings with Health Authorities. U.S. FDA experience with INDs and NDAs for nonprescription drugs.
Confirmed knowledge of ICH requirements plus hands-on experience with EMA, Health Canada or TGA medicine approval will be considered.
Direct experience participating in pre-submission meetings with regulatory agencies.
Knowledge of U.S. medical device clearance requirements and familiarity with ISO standards.
Bring us your passion and knowledge.
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 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 .
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.
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