Job Description

Your Job: The Director, Regulatory Affairs \xe2\x80\x93 APAC K-C Professional (KCP) & Consumer leads the regional regulatory affairs team for APAC (Asia-Pacific, Australia & China), and is responsible for establishing, implementing and maintaining required regulatory compliance for the business. The APAC Regulatory Affairs team provides strategic regulatory compliance leadership and also manage the proper filing of all required compliance documents, submissions and registrations for the region(s). This team also interacts with regional regulatory agencies to secure required product clearances and define regulatory strategies. In your role as Director, Regulatory Affairs \xe2\x80\x93 APAC, you\xe2\x80\x99ll help us deliver better care for billions of people around the world. A key objective of this leader is to elevate the region\xe2\x80\x99s 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 role will drive innovative regulatory strategies for product innovation and renovation. 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. About Us: People have looked to Kimberly-Clark brands for more than 150 years and today we\'re proud to help over a billion people around the world cope, laugh, love and live every day. From the best nappies and baby wipes to the softest tissues, to the best supplies for business, we are constantly searching for new ways to make life better for our consumers, our customers and our planet. Our leading consumer brands like the Kleenex, Huggies, VIVA, U by Kotex, Poise, Depend brands improve the lives of people around the world. Kimberly-Clark proudly leads the way in providing better care for a better world. Kimberly-Clark proudly leads the way in providing better care for a better world. Led by Purpose. Driven by You Role Overview & Primary Accountabilities: Strategic Business Partner:

• Responsible for providing Regulatory leadership for APAC that enables top line growth in core, developing and emerging markets by supporting regulatory initiatives and product innovation and renovation. Effectively translates regulatory requirements into meaningful advice for business leaders to support the organization\xe2\x80\x99s growth agenda. This leader will directly partner with and influence the senior business leadership teams
• 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 APAC region
• Partners and influences key stakeholders at all levels of the organization with a direct impact on K-C\xe2\x80\x99s product portfolio and operations. Exceptional stakeholder management, communication skills, business acumen and influential skills are required for this leadership position

Functional Expertise:

• Demonstrates understanding of medical device, chemical, consumer product, hygiene, general household, quasi drug, and cosmetic regulations. Has thorough understanding of and experience interfacing with regulatory bodies across multiple regions.
• This leader is directly responsible for directing, preparing and executing all product clearances, registrations, notifications, and submissions to the appropriate regulatory bodies in APAC such as local FDA, MOH, TGA, NHCC or CDSCO 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 / ELT informed of K-C\xe2\x80\x99s regulatory position, as well as provides input into QRC (Quality, Regulatory, and Compliance) Management Reviews for the region. Puts in place the programs, systems, structure and talent capabilities in the region 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
• Serves as a key regulatory compliance thought leader for APAC

Organizational Leadership:

• Provides leadership, direction and coaching to teams of regional Regulatory Affairs professionals responsible for regulatory requirements, registrations and market clearances, 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 regulatory direction for APAC including the development of goals, projects, and programs to enable the regulatory strategy.
• Nurtures a high-performance culture by strengthening Regulatory knowledge and capabilities across the APAC region and business teams. This includes leading the development and deployment of education and training to ensure awareness and usage of K-C\'s regulatory programs across APAC. Organizes the local regulatory team to support business objectives.
• Demonstrates exceptional change management skills leading the APAC 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.

Essential Requirements:

• A Bachelor\xe2\x80\x99s degree or Master\'s degree in Business, Engineering, Operations or equivalent degree
• Director or Senior Manager level of 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 directly interfacing with APAC regulatory bodies such as local FDA, MOH, TGA, NHCC or CDSCO.
• Demonstrated management experience within a complex, matrix or multi-business organization
• Ability to communicate at all levels of the organization and managing through complex compliance challenges to successful resolution
• Experience in an organization with Quality and Regulatory Affairs as a compliance function
• Experience leading a multi-business or multi-region regulatory affairs teams in a global organization
• 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\xe2\x80\x99s 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

About You: You\xe2\x80\x99re driven to perform at the highest level possible, and you appreciate a performance culture fueled by authentic caring. You want to be part of a company actively dedicated to sustainability, inclusion, wellbeing, and career development. You love what you do, especially when the work you do makes a difference. At Kimberly-Clark, we\xe2\x80\x99re constantly exploring new ideas on how, when, and where we can best achieve results. When you join our team, you\xe2\x80\x99ll experience Flex That Works: flexible (hybrid) work arrangements that empower you to have purposeful time in the office and partner with your leader to make flexibility work for both you and the business. What\xe2\x80\x99s on offer: Our Kimberly-Clark employees receive a competitive salary and incentives as well as access to a fantastic range of benefits including superannuation, career development opportunities, free health & well-being activities, volunteering leave and much more. To Be Considered: Click the Apply button and complete the online application process. A member of our Talent Acquisition team will review your application and will be in contact with additional information accordingly. In the meantime, feel free to browse our website for additional information on our company, brands and culture - Kimberly-Clark Corporation. Kimberly Clark is proudly accredited with as Employer of Choice for Gender Equality WGEA! Kimberly Clark is proudly ranked by Forbes as \'World\'s Best Employer\' 2021, 2022! 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, colour, religion, sex, national origin, disability 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 role is available for local candidates already authorized to work in the role\xe2\x80\x99s country only. K-C will not provide relocation support for this role.