Technical Leader-Regulatory Affairs at Kimberly-Clark Corporation in neenah, Wisconsin

Job Description:

Technical Leader-Regulatory Affairs

Job Description

Technical Leader-Neenah, WI

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 pesticide 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 customers include KCNA BCC and Family Care including their 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 and Consumer Tissue

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).


• The main challenges of the position are:
  
  
  • Understanding the various Kimberly-Clark domestic and international business needs.
  
  
  • Understanding and interpreting domestic and international regulations relative to new technology, and product development.
  
  
  • Having the ability to understand and provide extensive portfolio experience and the ability to provide technical aspects of the vast array of regulated products manufactured and/or marketed by the Kimberly-Clark business units.
  
  
  • Have the insight to problem-solve proactively on regulatory and associated quality issues.
  
  
  • Understanding various regulatory options for rapid commercialization of new technologies while keeping the businesses informed of costs, timing and competitive access.
  
  
  • Participate in Agency, Industry Association, SME internal and external colleagues as the technical export or leader for K-C.
  
  
  • Comply with K-C policies, internal controls and global regulations.
  
  
  
  

Principal Accountabilities:

• Demonstrate one K-C behaviors in all business interactions to ensure the GRA team attracts, develops and retains the best people and fosters an environment which motivates a diverse team to fully use its capabilities in achieving desired business results.


• 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 IMF 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, EPA, 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.  


• Provide advice and counsel to staff and global manufacturing facilities regarding compli­ance with FDA, EPA and Health Canada Quality System requirements, as well as international and national standards, when necessary. 


• 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. 


• Advanced capability to influence internally with two to three levels of the role. Serve as a liaison for GRA internally with QRC, legal and other regulatory resources throughout Kimberly-Clark as well as externally with FDA, EPA, Health Canada and international health ministries, and consulting organizations.  Perform all other regulatory functions as requested by the Team Leader.

Qualifications/Education/Experience Required:

• A broad technical background is required; preferably a graduate level degree, PhD, MBA or Masters, or as a minimum, a bachelor’s degree in a major scientific discipline preferably chemistry or microbiology and/or 8 to10 years of relevant technical experience, including FDA, EPA, and Health Canada regulations for cosmetics and/or pesticides, for example cosmetic registrations process. 


• Experience as a cosmetic formulator, or experience in EPA and FIFRA regulations for pesticides is highly desirable. 


• 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 cosmetic labeling, advertising promotion and claims review experience to ensure compliance with US FDA and Health Canada regulatory requirements.

Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, 1.3 billion people - nearly a quarter of the world's population - trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With more than 140 years of history of innovation, we believe in recruiting the best people and empowering them do their best work.  If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark. 

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.

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.

This position may require a post-offer/pre-hire Physical Abilities Test (PAT) to confirm that individuals are able to perform the essential functions of the job.

K-C requires that an employee have authorization to work in the country in which the role is based.  In the event an applicant does not have current work authorization, K-C will determine, in its sole discretion, whether to sponsor an individual for work authorization.  However, based on immigration requirements, not all roles are suitable for sponsorship. This position is subject to drug and alcohol testing, including pre-employment testing.

Global VISA and Relocation Specifications:

This role is available for local candidates already authorized to work in the role’s country only. K-C will provide relocation support for this role.

Primary Location

USA-WI-Neenah

Additional Locations

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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