Job Description

Relocation Assistance Offered Within Country
99800 - Piscataway, New Jersey, United States

*Candidate can be located at Toronto,CA or New Jersey or may work remotely but will be required to travel *

Do you want to be part of a team that is building a future to smile about? What about having the opportunity to connect with others across the world, full of stimulating discussions, and making impactful contributions?

If this is how you see your career, Colgate is the place to be!

Our dependable 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.

The Experience

In todays dynamic retail environment, it is an exciting time to be a part of the Research and Development at Colgate. Our highly upbeat and focused Team is dedicated to driving growth for Colgate Palmolive and for Ahold in this constantly evolving landscape.

What role will you play as a key member of the Global Technology Center?

The Manager / Associate Director Regulatory Affairs- North America, supports 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 professional U.S. Oral Care franchise. With a high degree of independence, the Manager of Regulatory Affairs applies regulatory intelligence and expertise to effect innovative regulatory pathways and solutions for sophisticated regulatory requirements to support Companys 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 also works closely with other co-workers in North America Regulatory to resolve whether new drug approval is required and to align on submission strategy.

Who are you...

* Serves as liaison and chief correspondent to USFDA and Health Canada on all drug and device pre-submission meetings and lifecycle submissions.
* Interprets and communicates health authority correspondence optimally and quickly to senior leadership and clinical project teams.
* 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 that are consistent with business plans and regulator expectations.
* Plans and supervises regulatory submissions and all post-marketing commitments.
* 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 to ensure adherence throughout the product lifecycle.
* 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).
* Establishes positive relationships with Corporate and North America Division partners such as Marketing, Legal, Technology, Supply Chain and Product Safety, to ensure tight alignment among Regulatory strategies, product development and business goals.
* Represents Colgate to trade associations as assigned, and provides clear updates to partners as vital.



What you will need:

Required qualifications:

* Bachelor's Degree and confirmed ability showing progression through roles of growing responsibility.
* At least 15 years of proven experience on the regulatory affairs space.
* Direct, recent experience in new drug approval process and leading face-to-face meetings with Health Authorities. U.S. FDA experience with INDs and NDAs for nonprescription drugs is strongly preferred.
* Validated knowledge of ICH requirements plus hands-on experience with EMA, Health Canada or TGA medicine approval will be considered.



Preferred Qualifications:

* Knowledge of U.S. medical device clearance requirements and familiarity with ISO standards is desired.
* Advanced Degree in Chemistry, Biology, Regulatory Affairs or related

This position can be performed remotely ideally on Eastern and Central Time Zone.



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

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.

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, Toms 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 Hills Science Diet and Hills Prescription Diet.

For more information about Colgates global business, visit the Companys 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 Hills Food, Shelter & Love program please visit http://www.hillspet.com. To learn more about Toms 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.