Director, Global Regulatory Affairs
Director, Global Regulatory Affairs
Director, Global Regulatory Affairs - Kimberly Clark Professional
The Director, Global Regulatory Affairs provides leadership, direction and management in the implementation of regulatory policies, procedures and strategies to ensure domestic and global regulatory compliance for K-C’s B2B business, K-C Professional (KCP). Provide vision and direction to KCP businesses concerning global market entry strategies and tactics as well as growth opportunities for existing categories.
This individual reports to the Sr. Director, Global Regulatory Affairs. The incumbent provides leadership, coordination and development of global center of excellence within RA and across the Enterprise with focus on the KCP business. He/she leads the development and implementation of the critical systems and processes necessary to ensure regional and global regulatory compliance for the KCP business. Essential to this leadership position is to successfully integrate into the KCP business as a valued partner ensuring that R&E / Business Unit platforms, programs and innovation activities focus on current and future regulatory compliance requirements while simultaneously maintaining regulatory compliance for marketed products and geographic expansion. He/she provides protection to Kimberly-Clark brands and reputation through the application of product sustainability programs.
- Interpret and communicate current national, regional and global regulations as applicable to North America (NA) that cover a broad product range including personal protective equipment, biocides, cosmetics, consumer products, and electrical products; identify and communicate the impact of the regulations to the relevant KCP R&E, Quality, Procurement, business teams and to senior leadership
- Serve as the regulatory lead for the KCP Global Industrial Safety and Scientific businesses (which includes Infection Prevention and Disinfectant) and coordinate regulatory activities associated with new product development, market introduction/expansion and regulatory compliance with the EMEA, LAO and APAC regulatory leads; lead the development of unified strategies and implementation for these businesses to deliver business results;
- Anticipate, monitor and influence changing NA regulatory landscape applicable to all KCP major product categories; Assess emerging regulation changes and develop solutions to them
- Determine applicability of new or proposed changes of NA regulations on marketed products and the innovation pipeline, communicating these developments to R&E, senior business leaders and platform managers;
- Participate in project teams developing new products to define regional regulatory, Industrial Safety and Scientific technical and quality requirements;
- As the regulatory lead for the KCP Global Industrial Safety and Scientific businesses, coordinate KCP global/regional registration activities with regional/local regulatory teams and serve as the lead interface with global/regional product development teams;
- Design and implement strategies, processes and procedures to ensure that KCP products comply with local regulatory requirements within NA; ensure that K-C is not exposed to risks due to non-compliance in a dynamic regulatory environment;
- Manage a team of RA professionals and influence functional teams in the development of relevant data to complete a regulatory submission. Prepare regulatory submissions, registrations, notification, certifications in accordance with national and regional regulatory requirements to facilitate global market expansion in accordance with business launch plans;
- Initiate, develop and implement tools and strategies to improve business systems relating to the operation of the regulatory affairs, technical and quality teams;
- Serve as KCP’s official correspondent with NA designated regulatory agencies (e.g. USFDA, NIOSH);
- Leverage global consulting network to provide targeted expertise for concepts and new product development requirements; communicate these to the requisite business/project teams and utilize this network to facilitate global market expansion;
- Build knowledge bank and make available a single source of global regulatory requirements for the various product categories commercialized by the KCP business providing transparency to the level of regulatory complexity and associated costs for senior business leaders with particular focus on the KCP Global Industrial Safety and Scientific platforms;
- Ensure timely, concise, accurate and responsive communications with relevant people in the organization;
- Provide leadership and advise business on complaint handling, adverse event reporting requirements and NA post market surveillance requirements; evaluate information provided by businesses on adverse events and execute requisite reporting to regulatory agencies as required;
- Review and approve business unit recall strategies and implement recall activities with national and regional regulatory agencies;
- Review risk mitigation plans and monitor ongoing results;
- Lead the Regulatory Workstream on quality review board and crisis management teams;
- Ensure regulatory accuracy on corporate communications concerning crisis situations and other social media activities;
- Conduct due diligence for partnerships, mergers, acquisitions, licensees, etc.;
- Provide advice concerning external regulatory audits and provide subject matter expertise to formulate audit strategies and responses;
- Actively participate in the regulatory component of product stewardship activities with appropriate participation on the Product Stewardship Council;
- Develop and execute regulatory strategies that will ensure compliance with global, regional and national chemical regulations In tandem with the KCP EMEA, APAC and LAO RA leaders for a unified approach to reporting requirements such as REACh and SVHC mandates;
- Perform other tasks and activities as directed by the Sr. Director RA.
Expectations and Accountabilities:
The incumbent will assume a strategic lead role representing the regulatory perspective while proactively developing new and innovative approaches for pursuing business objectives within the regulatory framework. Will lead their respective RA team, responsible for providing regulatory strategies, preparation of regulatory submissions and registration services. This position includes responsibilities related to strategic planning and interfacing throughout the product lifecycle, both within the organization and with diverse external groups. The incumbent will:
- Ensure that all elements of the Corporate Code of Conduct are fully supported;
- Ensure that all elements of the corporate Human Resources Development and Diversity policy are fully supported; contribute to an environment in which all team members are respected regardless of their individual differences, and are motivated to improve both their individual and team contributions to achieve desired business results;
- Manage teams and self in accordance with the One K-C behaviors and leadership qualities associated with this role;
- Select, develop, coach and evaluate team members to ensure the efficient operation of the function, project completion, and system development;
- Prepare and implement unit budgets and schedules; implement appropriate controls as required;
- Execute all regulatory activities in accordance with corporate policies and practices, protection of proprietary information, and compliance with applicable laws and regulations.
- Communicate appropriately with all customers, conducting all communications and transactions with the utmost integrity and honesty so as to build an unimpeachable business reputation.
- Maintain a high standard of professional performance to serve as an example with respect to compliance and technical judgment, concern for K-C competitive position and consideration for people.
Primary customers include the Global Kimberly-Clark Professional business unit including its respective management team as well as global, regional and sector business leaders and teams. Internal customers also include mill/plant operations and quality management teams, the KCP quality teams, R&E, Legal, Corporate Security, Corporate Communications, Global Quality, Global Clinical Affairs, Global Product Safety, Procurement, Transportation, Logistics, Product Supply and Environmental and Sustainability teams. External customers include key regulatory and/or certification agencies, opinion leaders, suppliers and contract manufacturers.
- Requires a Bachelor’s degree in a science, engineering or related discipline
- 15+ years industrial experience or another equivalent combination of education and experience.
- Demonstrated evidence of a solid background of technical knowledge and experience in regulatory affairs combined with the proven ability to successfully direct projects and influence people at all organizational levels.
- Experience with scientific, safety, pesticide or biocides industries and/or products is absolutely critical.
- Experience leading global teams and large-scale initiatives.
- Ability to drive decision making is critical to this position.
The annual budget for the Global Director position can range from $ 0.1 – 0.5 M and the incumbent is responsible for product portfolios valued at over $3.5 B in global sales. Reporting to the incumbent will include the Sr Regulatory Affairs Manager in LAO and APAC as well as the KCP EMEA RA Associate Director; additional regulatory positions in NA also report to leader for an overall organization of 10 professionals.
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.
Kimberly-Clark is an 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.