Director, Regulatory Affairs

The** **Director, Regulatory Affairs - 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.

A key objective of this leader is to elevate the region’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 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.

This role reports directly to the Sr Director, Global Regulatory Affairs, and we are open to the role being located in either: Singapore, China, Hong Kong, Malaysia or India.

**Position Description**

**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’s 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’s 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’s 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 t