Manager, Regulatory Affairs
Our client is a global developer, manufacturer, and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning, and disinfection products. They are looking for a Regulatory Manager for their Northern NJ location.
The Regulatory Manager is responsible for providing strategic and tactical direction as well as the execution of Regulatory activities in support of our existing portfolio and a new pipeline of wet wipes products.
In this key role, the Manager will advance business and project objectives via the development of regulatory strategies and plans, including the preparation and execution of product registrations and filings.
He/ she will ensure full regulatory compliance of our wet wipes under their relevant product classification for the US market, with potential broader regulatory roll-out to Canada, EU, and other global regions. The Regulatory Manager will provide oversight and guidance on product claims, label requirements, and the impact of any changing regulatory requirements.
ESSENTIAL FUNCTIONS AND BASIC DUTIES:
- Provide regulatory leadership in support of existing business and new project initiatives
- Leverage extensive knowledge and prior expertise in providing regulatory strategies/plans for our portfolio of wet wipes products, which include cosmetics, OTC/FDA and EPA registered wipes within the US, Canada, EU, and other markets
- Ensure that all regulatory activities related to the maintenance of existing products and the development of new products are conducted and delivered in a high quality and fully compliant manner
- Oversee and optimize current regulatory processes, including input into project regulatory strategies, registration filings based on product classification, regulatory documentation, artwork, and claims review, and ongoing monitoring of the regulatory landscape
- Evaluate and clearly communicate to management any identified regulatory risks/gaps and trade-offs for the product/project portfolio and develop mitigation/contingency plans for identified risks
- Support new product innovation by developing relationships with Regulatory Authorities to understand how to maximize our investments through the regulatory process
- Analyze and execute all statutory reporting requirements and assist in the response to any product adverse health effects complaints
- Prepare, maintain and work with an outside consultant where needed to update regulatory non-clinical safety & environmental files as needed
- Represent the Client’s interests in the areas of regulations and product safety with government agencies, industry associations, and other organizations as directed
- Develop and maintain strong, collaborative internal partnerships (e.g., R&D, Quality, Legal, Marketing, Operations, etc.) to facilitate workflow and information sharing in support of registration package development for countries of launch
- Lead the development of and enhance the visibility of the Regulatory & Product Safety Team to effect positive culture change throughout the organization
- Work with senior management to optimize talent development and to develop necessary skills training
- BA/BS in a relevant technical degree is required; an advanced degree such as an MS is a plus
- Extensive knowledge of cosmetic, OTC/FDA, and EPA regulations for the US market is required; knowledge of global regulations is a plus
- Understanding of personal care and household product regulations and a well-established network of industry connections
- 10+ years of relevant experience in regulatory and product safety roles for consumer products; prior experience with cleansing wipes is a plus
- Proven track record of delivery in regulatory roles with prior participation, influence, and impact with external committees and regulatory bodies
- Minimum of 5 years of management experience leading regulatory, product safety professionals
- Proficiency with electronic submissions/regulatory filing systems
- Prior experience and scientific expertise in the non-clinical, clinical, toxicological, and/or operational (CMC) areas
- Ability to strategize, execute, develop and improve regulatory and product safety systems for compliance and efficiencies
- Leadership capabilities and ability to manage a team and a portfolio of projects to meet the business objective
- Creativity and the ability to address and deliver new regulatory opportunities outside of the company’s core/current areas
- Excellent communication and presentation skills communication skills, to be able to deal effectively with all levels of the organization and our customers/clients
- Strong understanding of the role of the consumer and business/brands and the ability to balance these needs alongside the rational requirements of the commercial business and technical constraints of manufacturing processes
- Proven results in building strong customer relationships, anticipating customer needs, and delivering consumer-centric solutions
For more info on this & other exciting roles please contact me
C: 914-262-5142 E: firstname.lastname@example.org
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
Job posted: 2021-02-01