GLOBAL REGULATORY AFFAIRS TECH LDR Job in Neenah 54956, Wisconsin Us

Job Description:
Technical Leader-Global Regulatory Affairs
Neenah, WI or Roswell, GA
Hay Point 725

Kimberly-Clark is leading the world in essentials for a better life. Headquartered in Dallas, Texas, with nearly 56,000 employees worldwide and operations in 36 countries, Kimberly-Clark posted sales of $19.7 billion in 2010. Kimberly-Clark’s global brands are sold in more than 150 countries. Every day, 1.3 billion people trust Kimberly-Clark products and the solutions they provide to make their lives better. With well-known family care and personal care brands such as Kleenex, Scott, Andrex, Huggies, Pull-Ups, Kotex, Poise and Depend, we hold the No. 1 or No. 2 share position globally in more than 80 countries.

As a global company, we are committed to cultivating a fair, respectful and engaging work environment that inspires our diverse global team to thrive professionally and contribute to the communities where we operate. We also have a responsibility to attain a deeper understanding of our impact on the world. Addressing Sustainability issues and incorporating solutions through all levels of Kimberly-Clark is a critical component of our business.

Position Purpose:

Provide technical leadership in the development and implementation of regulatory strategies to support the achievement of business objectives for client K-C business units, while ensuring compliance with domestic and international drug, device, and consumer product regulations, with a strong focus on the FDA, Health Canada and Consumer Product Safety Commission Agency and European Union medical device and consumer product requirements for new product development. Provide regulatory training and strategic regulatory assessments to the research and development teams in support of new technology development that is cognizant of product testing and other requirements for regulatory approval in global markets.
Customers:

Primary customers include the NACP, K-C International, and KCP business units including their respective management team, the global business team members; mill/plant operations and quality management teams, RE, Legal, Quality Assurance, Global Clinical Affairs, Global Product Safety, Purchas¬ing, Logistics, suppliers and contract manufacturers.
Expectations:

  • Develop and implement domestic, international, and where appropriate, product specific regulatory strategies in support of business objectives.
  • Prepare accurate regulatory submissions to secure timely approvals in support of business initiatives.
  • Monitor the development of regulatory initiatives and communicate potential business impact to senior management.
  • Provide an interpretation of regulatory requirements, both domestic and international to the appropriate business team members and highlight implications of differences with respect to product development and testing activities so as to minimize overall development activities while bring speed to the global registration process.
  • Conduct training seminars on domestic and international regulatory requirements and/or impending regulations to the appropriate business team members to enable the best global development activities.
  • Implement and maintain systems to ensure accurate, complete and timely submissions to regulatory agencies.
  • Anticipate and assist in the resolution of regulatory and/or quality issues and recommends corrective action.

    Scope:

    The incumbent is responsible for establishing and maintaining harmonized global regulatory management systems designed to effectively and efficiently support global 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 units.

    The main challenges of the position are:

  • Understanding the various Kimberly-Clark domestic and international business needs and leveraging these against regional and country registration requirements.
  • Understanding and interpreting domestic and international regulations relative to new technology and product development.
  • Having the ability to understand the 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.
  • Comply with K-C policies, internal controls and global regulations

    Qualifications/Education/Experience Required:

  • Bachelor’s degree in a major scientific discipline, preferably chemistry or microbiology
  • A broad technical background
  • 8 to10 years of relevant technical experience, including direct experience in compliance with FDA, Health Canada over-the-counter drug and medical device regulatory approval process,
  • European medical device directive and other consumer product regulations such as RoHS and the US and Canadian Consumer Product Safety Commission regulations, specifically CPSIA and CCSPIA.
  • Additional experience with the EPA and FIFRA regulations for pesticides and/or with the European Biocide Directive is highly desirable.
  • The incumbent must possess an understanding of process, manufacturing, engineering, market research, marketing and legal matters obtained through experience and/or advanced education.

    Preferred Qualifications:

  • Advanced Degree (MBA or equivalent) preferred.

    Please apply at Req ID: 14308

    Click here to apply via the Kimberly Clark Career Opportunity Portal

    Minimum Education Required: Bachelor

    Years of Experience Required: 3-5 Years

    Expected Travel Time: About 25%

    This company may offer relocation assistance.