Senior Director, Global Regulatory Affairs
Kimberly-Clark Corporation, Roswell Georgia
Senior Director, Global Regulatory Affairs
Location: Roswell, Georgia or Neenah, Wisconsin
SUMMARY OF POSITION:
The Sr Director, Global Regulatory Affairs represents the Regulatory Affairs organization as a member of the senior Quality, Regulatory and Compliance (QRC) leadership team reporting to the Chief Quality Officer. This leader is responsible for establishing, implementing and maintaining required regulatory compliance for all K-C businesses (Consumer and B2B) across KCNA, EMEA, APAC and LAO. The Global Regulatory Affairs team provides strategic regulatory compliance leadership and also manages the proper filing and licensing of all required compliance documents, submissions and registrations. This team also interacts with global regulating agencies to secure product approvals and define regulatory strategies.
A key objective of this leader is to elevate K-C’s regulatory compliance position by building regulatory intelligence, maintaining audit readiness and proactively managing market-by-market compliance to meet or exceed the expectations of regulatory bodies. This individual must proactively address complex regulatory issues and stay ahead in the regulatory environment by anticipating changes before they occur. In addition, the role must engage with and influence K-C leaders at all levels across Quality, Product Safety, Supply Chain, Legal, and R&E (R&D), helping the teams achieve key business goals and expectations.
Strategic Business Partner
- Responsible for providing Regulatory leadership that enables top line growth in core, developing and emerging markets by supporting sustainability initiatives and product innovation and renovation. Effectively translates regulatory requirements into meaningful advice for business leaders to support the organization’s growth agenda.
- Monitors the development of new regulatory requirements or guidance documents and advises product teams of the impact on the business and development programs. Provides support to Regulatory Affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
- Informs senior management teams of significant issues or developments identified during regulatory activities, as well as actions being taken to improve the situation through regular participation with regional and local teams.
- Stays abreast of trends/developments in government and industry regulatory standards and requirements. Develops strategies for ensuring K-C programs, policies and procedures meet or exceed external regulatory requirements. Represents K-C on industry association regulatory committee(s) and provides strategic advice and input into policies and regulations being developed by global regulatory bodies.
- Partners and influences key stakeholders at all levels of the organization with a direct impact on K-C’s product portfolio and operations. Exceptional stakeholder management, communication skills, business acumen and influential skills are required for this leadership position.
- Demonstrates understanding of medical device, consumer product, and cosmetic global regulations. Has thorough understanding of and experience interfacing with regulatory bodies across all regions.
- Develops, maintains and reports out a Global Regulatory dashboard with critical KPIs to keep senior management informed of K-C’s regulatory position, as well as provides input into QRC Management Reviews across all regions. Puts in place the programs, systems, structure and talent capabilities to ensure we meet our objectives of zero regulatory actions against K-C, as well as zero regulatory inspections with critical or repeat observations.
- Is accountable for the development and implementation of new Regulatory Affairs concepts or initiatives to improve the way business, facilities, and functions perform duties to achieve QRC objectives.
- Serves as a key regulatory compliance thought leader for the enterprise and QRC organization. Serves as K-C’s highest-level Regulatory representative.
- Provides leadership, direction and coaching to a global team of regional Regulatory Affairs professionals responsible for regulatory registrations and pre-market approvals, as well as managing statutory and regulatory inspections. This includes establishing the right organization strategy, capabilities, structure, management processes and talent strategies. Sets the strategic RA direction and leads all aspects of strategy deployment and medium- to long-term planning, including the development of goals, projects and programs to activate the RA strategy.
- Nurtures a high-performance culture by strengthening Regulatory knowledge and capabilities across every function and level of the organization. This includes leading the development and deployment of education and training to ensure awareness and usage of K-C's Regulatory and Compliance programs across the Enterprise.
- Demonstrates exceptional change management skills leading the Global RA function through the Quality Transformation at K-C with the focus of always doing the right thing for our consumers and employees. Ongoing communication will be a critical accountability to lead through this change.
GENERAL EXPECTATIONS AND ACCOUNTABILITIES:
- Promotes and demonstrates safety as a value by performing all job functions safely while also complying with corporate policies and departmental procedures in an effort to reduce risk, ensure consumer safety and eliminate loss.
- Manages self in accordance with the expected One K-C Behaviors commensurate with Role (Sr. Executive).
- Develops and administers quality organizational feedback, culture or accountability and other management tasks (recruiting, onboarding, training, talent management, etc.). Provides feedback, coaching and work direction to team leaders and team members.
- Ensures that established manufacturing inspection, sampling and statistical process controls procedures are followed as applicable.
- Maintains and demonstrates a high degree of knowledge and skill in product form and quality systems, processes and regulations.
- Establishes and maintains positive customer rapport, while driving solutions to meet business needs. Develops and maintains a strong spirit of partnership.
- Conducts all communications and transactions with the utmost integrity, consistent with the K-C Code of Conduct.
- Promote and support continuous improvement activities for established processes and development of new processes.
- Travel 20 to 50% of the work time.
- Work is completed in both an office environment and at R&E or R&D and/or manufacturing facilities. When at R&E or R&D or manufacturing facilities, the employee will be exposed to environments ranging from those with dust, heat, noise and moisture, up to clean room / laboratory environments. Proper personal protective equipment (PPE) must be worn at all times (may include safety glasses, ear protection, hair nets, beard bags (if applicable), full gowning.
- A Bachelor’s degree in Business, Engineering, Operations or equivalent degree.
- 15+ years of experience in a regulatory leadership role in a medical device, pharmaceutical, consumer goods, cosmetic or similar environment.
- Deep subject matter expertise in regulatory compliance requirements for medical devices and/or pharmaceutical or cosmetics. Interaction and experience working with various regulatory bodies across the globe as well as working knowledge of pre-market approvals (e.g., US FDA Medical Device 510(k) pre-market approvals; CE Marking-PPE/Medical Devices; EU Biocide/Cosmetics regulatory requirements; FDA OTC Drug requirements; EPA Pesticides/NIOSH PPE requirements; Latin America-Cosmetics/PPE regulatory requirements; and APAC Medical Device/Cosmetic pre-market approvals).
- Demonstrated management experience within a complex, matrix or multi-business organization.
- A Master’s degree in Business, Engineering, Operations or equivalent degree.
- Experience in an organization with Quality and Regulatory Affairs as a compliance function.
- A minimum of 5 years leading a global/central Regulatory Affairs function.
- Exceptional leadership skills and passion for organizational and talent development. Strong track record of leading organizations through change and serving as an inspirational leader to the teams.
- Experience building a global Regulatory Affairs function that proactively manages regulatory requirements while also supporting the organization’s growth agenda.
- Experience leading global teams responsible for the execution of regulatory registrations, pre-market approvals, and management of regulatory/statutory inspections.
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