Regulatory Affairs Product Manager

Full Time
Madison, WI
Posted
Job description

You’re not the person who will settle for just any role. Neither are we. Because we’re out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a difference. Here, you’ll bring your professional expertise, talent, and drive to building and managing our portfolio of iconic, ground-breaking brands. In this role, you’ll help us deliver better care for billions of people around the world. It starts with YOU.

Position Purpose:

  • Provide functional and technical leadership in the development and implementation of regulatory strategic direction to support the achievement of business objectives for client K-C business units, while ensuring compliance with domestic and international cosmetic and consumer product regulations.
  • Provide regulatory product strategies, influence, and make strategic recommendations and input to other QRC functions for a cohesive QRC response to the business units that will ensure corporate compliance with the regulations.
  • Provide regulatory training and influence strategic decision making to regulatory colleagues, the research and development teams and cross functional partners in support of new technology development that is cognizant of product testing and other requirements for regulatory approval in global markets in order to meet launch timelines.

Customers:

Primary customer is KCNA including respective management teams, global business management teams; R&E, Legal, and QRC functions including Business Quality, Global Quality Assurance, Global Product Safety and Clinical Affairs, Global Medical Affairs, Purchasing, Logistics, suppliers and contract manufacturers.

Expectations:

  • Provides regulatory affairs leadership and support in the development, improvement programs and/or projects involving department or cross-functional teams.
  • Communicate appropriately with all customers, conducting all communications and transactions with the utmost integrity and honesty so as to build an unimpeachable business reputation.
  • Provides technical leadership and expertise to support teams in manufacturing and marketing full ranges of products in the US and Canada.
  • Manage teams and self in accordance with the expected behaviors of the Leadership Qualities.
  • Develop and implement domestic, international, and where appropriate, product-specific regulatory strategies in support of business objectives.
  • Monitor the development of regulatory initiatives and communicate potential business impact to business and QRC senior management.
  • Provide interpretation on and training of domestic and international regulatory requirements to the appropriate business and QRC partners and team members.
  • Anticipate and assist in the resolution of regulatory and/or quality issues and recommends corrective actions.

Dimensions:

$16 Billion in sales volume Personal Care

Scope:

  • The incumbent is responsible for establishing and maintaining regulatory strategies designed to effectively and efficiently support business objectives.
  • This individual provides analytical, interpretive and evaluative solutions to complex problems through specialized quality and regulatory expertise based on an in-depth knowledge of technical and business practices.
  • The incumbent integrates and coordinates activities within clearly defined policies; helps develop and champion regulatory policies; relies on an ability to understand and motivate people without direct authority; and is responsible for providing services to client business(es).

Principal Accountabilities:

  • Provide strategic and functional leadership, expertise and counsel that result in the development, manufacture and placing on the market products that provide quick and cost-effective routes to market, and which comply with the applicable regulatory requirements.
  • Represent Kimberly-Clark’s interests at Trade Associations, in order to gain knowledge and influence regulations and standards by collaborating with other similar companies.
  • Actively participate in the Innovation process and project teams by providing targeted feedback on proposed product formulations and/or product designs to ensure potential regulatory hurdles are identified at the earliest stages of a project and appropriate business decisions can be made.
  • Establish and maintain processes and provide leadership to ensure that regulatory submissions and responses, such as those for FDA and Health Canada and various international regulatory submissions are prepared and submitted accurately and completely in a timely manner to meet business objectives
  • Establish and maintain an information network for purposes of monitoring domestic and international regulatory developments, followed by appropriate preventive communication and training within the K-C business units.
  • Lean in to challenging communication situations both internally and externally to ensure business outcomes.
  • Provide consultation and guidance relative to the resolution of regulatory and/or quality issues and non-compliances.

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Qualifications/Education/Experience Required:

  • A broad technical background is required; a bachelor’s degree in a major scientific discipline and/ 5+ years or a Masters degree with 3+ years of relevant technical experience, including FDA and Health Canada regulations for cosmetics, medical devices and OTC drugs or consumer products.
  • Must possess an understanding of the product development process including product design/formulation, manufacturing, engineering, marketing and legal matters obtained through experience and/or advanced education and the implications on a global launch of a given product.
  • The incumbent must also possess extensive experience with labeling, advertising promotion and claims review experience to ensure compliance with US FDA and Health Canada regulatory requirements.

Total Benefits

For a complete overview, see www.mykcbenefits.com


Veterans and members of the Reserve and Guard are highly encouraged to apply.

For Kimberly-Clark to grow and prosper, we must be an inclusive organization that applies the diverse experiences and passions of its team members to brands that make life better for people all around the world. We actively seek to build a workforce that reflects the experiences of our consumers. When you bring your original thinking to Kimberly-Clark, you fuel the continued success of our enterprise. We are a committed equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, age, pregnancy, genetic information, citizenship status, or any other characteristic protected by law.

Additional information about the compensation and benefits for this role are available upon request. You may contact 866-444-4516 or kcchrprod@service-now.com for assistance. You must include the six digit Job # with your request.

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

K-C will support in-country relocation for the chosen candidate for the role, including assistance to obtain proper work authorization. The benefits provided will be per the terms of K-C’s applicable mobility policies. The benefits/policy provided will decided in K-C’s sole discretion.

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