RA Director, Enterprise Markets

at  KimberlyClark

ABOUT US

Huggies®. Kleenex®. Cottonelle®. Scott®. Kotex®. Poise®. Depend®. Kimberly-Clark Professional®. You already know our legendary brands—and so does the rest of the world. In fact, millions of people use Kimberly-Clark products every day. We know these amazing Kimberly-Clark products wouldn’t exist without talented professionals, like you.
At Kimberly-Clark, you’ll be part of the best team committed to driving innovation, growth, and impact. We’re founded on 151 years of market leadership, and we’re always looking for new and better ways to perform – so there’s your open door of opportunity. It’s all here for you at Kimberly-Clark.
Led by Purpose. Driven by You.

ESSENTIAL REQUIREMENTS

• Min 10 years experience in Regulated Manufacturing, Quality or Regulatory Affairs roles.
• Bachelors Degree or Masters degree in Business, Engineering, Operations or equivalent degree.
• Experience in a regulatory or compliance role in a medical device, chemical, pharmaceutical, consumer goods, cosmetic or similar environment with demonstrated leadership experience
• Deep subject matter expertise in regulatory compliance requirements for medical devices, 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., Medical Device, Consumer, Hygiene, General household, or quasi drug requirements)
• Experience in engagement with Agency and notified bodies to enable regional or country market access.
• Ability to communicate at all levels of the organization and managing through complex compliance challenges to successful resolution
• 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 Regulatory Affairs team that proactively manages regulatory requirements while also supporting the organization’s growth agenda
• Experience leading regulatory teams responsible for the execution of regulatory registrations, pre-market approvals, and management of regulatory/statutory inspections for multiple businesses/regions
• Role model of K-C Ways of Working

• Responsible for providing Regulatory leadership for Enterprise markets that enables top line growth in EMEA, LATAM, SEA markets by supporting regulatory initiatives, product innovation, renovation and life cycle management. Effectively translates regulatory requirements into meaningful regulatory strategy for business leaders to support the organization’s growth agenda. This leader will act as the QRC ambassador that will provide strategic direction to the Enterprise market business to enable market access and compliance.
• Ensures the monitoring of the emerging 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 in the business or region 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 for the Enterprise Market Segment
• Partners and influences key stakeholders at all levels of the organization with a direct impact on K-C’s product portfolio and operations.
• This leader is directly responsible for directing, preparing and executing all product clearances, registrations, notifications, and submissions to the appropriate regulatory bodies in the Enterprise Market Sector such as local EU, INVIMA, MOH, TFDA, submissions to ensure all regulatory requirements are met before marketing a K-C product.
• Directly enables the reporting and management of critical KPIs to keep senior management informed of K-C’s regulatory position, as well as provides input into QRC (Quality, Regulatory, and Compliance) Management Reviews for the regions. Puts in place the programs, systems, structure and talent capabilities in the regions to ensure we achieve regulatory compliance.
• Is accountable for the development and implementation of new Regulatory Affairs concepts or initiatives to improve the way business, project, facilities, and functions perform duties to achieve QRC objectives