Nice-Pak Job - 35449515 | CareerArc
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Company: Nice-Pak
Location: Montvale, NJ
Career Level: Mid-Senior Level
Industries: Retail, Wholesale, Apparel

Description

Nice-Pak Products, Inc. (NP) is the global developer, manufacturer, and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning, and disinfection products. 

We're currently looking for a Regulatory Manager in our Montvale, NJ location.

POSITION PURPOSE:

The Regulatory Manager position within the Nice Pak Organization 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. This position is an ideal opportunity for any individual looking to leverage his/her regulatory expertise to support business development and drive innovation, with an opportunity for career advancement in a dynamic, fast-paced, and challenging work environment.

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 Nice Pak 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

PERFORMANCE MEASUREMENTS:

  • Achievement: Ability to manage time and resources to deliver aligned objectives on time, without issue, and in a quality manner
  • Ownership: Ability to demonstrate strong and independent ownership of assigned responsibilities for regulatory activities and programs within the organization
  • Partnership Skills: Ability to work very well cross-functionally, communicate effectively and work as part of a team to achieve objectives
  • Entrepreneurial Skills: Ability to demonstrate creativity in the role, explore and deliver new and out-of-the-box solutions

QUALIFICATIONS:

EDUCATION/CERTIFICATION:

  • BA/BS in a relevant technical degree is required; an advanced degree such as an MS is a plus

REQUIRED KNOWLEDGE:

  • 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

EXPERIENCE REQUIRED:

  • 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

SKILLS/ABILITIES:

  • 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

WORKING CONDITIONS:

  • Office environment with some travel to conferences/committees as well as potential customer visits

 

 

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