LOCATION: PISCATAWAY, NJ
Our client, a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition is seeking a Manager of Regulatory Affairs for their Piscataway, New Jersey location. Please note that relocation assistance is offered within country.
The Manager of Regulatory Affairs will support the 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 required to maintain and 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, Medical Device 510(k), OTC Monograph, and Cosmetic designations.
This position may also have some responsibility for Personal Care and Home Care products, and 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.
The Manager of Regulatory Affairs will be responsible for managing day to day regulatory activities for assigned projects, and working with Regulatory management in developing regulatory strategy and recommendations for the U.S. This person will also be responsible for coordinating with Regulatory Affairs - Canada on all product support for similar projects.
About the responsibilities:
• Represent and strengthen the expertise in regulatory processes and procedures, using business knowledge to enable development of actionable regulatory and registration strategies.
• Support the Global Technology innovation platforms for existing and new products.
• Communicate the impact of changes in the regulatory environment on the Business and work with the U.S. Regulatory Affairs team to 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 on a cross-functional basis including Marketing, Legal, Technical, Supply Chain, Regulatory and Product Safety, to ensure perfect alignment and synchronization between Regulatory processes and strategies and Business goals and programs.
• Maintain Regulatory filings and Health Authority communications through electronic and paper records in a timely and efficient manner.
• Provide Regulatory guidance and advice to R&D, and Divisional stakeholders.
• Stay abreast of current and new U.S. Drug, Device and Cosmetic regulations and guidelines, and ensure adherence throughout product life cycle.
• 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. Communication with business and technical partners to shape product development approaches to minimize regulatory impact.
• In consultation with other Regulatory Affairs staff develop a complementary role through selective trade association representation e.g. joint CHPA/PCPC working groups on anti-caries, and CHPA Fluoride Prop 65 Working Group, etc, and clearly provide updates to the North American Regulatory team as necessary.
• Ensure that regulatory registrations are supported appropriately for the U.S. and are of quality and filed in accordance with agreed upon business timelines.
About your qualifications
• Bachelor’s Degree with a minimum of 10 years of regulatory experience required. A Master’s degree highly preferred.
• Working knowledge of U.S. regulatory requirements and regulations (Cosmetics, Drugs and CPG or Medical Devices) required
• Strong interpersonal and relationship building skills
• Strong communication and presentation skills
• Strong decision-making skills
• Strong experience with management of multidisciplinary projects
Qualified candidates should email their resumes to email@example.com