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
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.