Advisor, Regulatory Affairs

2 months ago

Mumbai, India Kimberly-Clark Full time

The GRA **Advisor, Regulatory Affairs - APAC** provides vision, direction, and advice in the implementation of APAC regulatory strategies to ensure regional management of Consumer, Professional or enterprise innovation level regulatory compliance. The incumbent will strategize with, communicate, and advise business on anticipated and existing regulation and legislation in support of product development and regulatory compliance during life cycle management of the K-C product portfolio.

The incumbent will be primarily responsible for providing innovative, regional regulatory strategies to manage innovation and preparation of regulatory clearances to enable the business to achieve objectives while ensuring that K-C complies with applicable regulatory requirements governing our products.

The incumbent provides leadership, coordination, and development of regulatory affairs strategies for the APAC region and its innovation teams. This position will assess the regulatory impact and risk associated with changing legislation across the region, and subsequently provide the vision to ensure platforms, programs and innovation activities incorporate these compliance requirements into innovation, product development and life cycle management to ensure regulatory compliance

A key objective is to elevate the APAC regulatory compliance position by building a model for regulatory execution, support global regulatory intelligence, and proactively advising on the path to 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.

In addition, the role must engage with and influence K-C leaders at all levels across all functions, helping the teams achieve key business goals and expectations. Business awareness and acumen are critical to success.

This role reports directly to the Sr Director Regulatory Affairs.

**ESSENTIAL ACCOUNTABILITIES**:

- Execute all regulatory activities in accordance with corporate policies and practices, protection of proprietary information, and compliance with applicable laws and regulations.
- Act as primary interface for APAC regulatory affairs with the Innovation Teams. Act as liaison with global innovation team and regulatory technical leaders.
- Develop and maintain an appropriate regional regulatory governance process to execute regional and global projects.
- Support product development activities and in accordance with enterprise or business launch plans.
- Develop and execute regional or global, innovative regulatory strategies that will ensure compliance with regulations.
- Ensure coordination and interaction with regional and/or global teams to enable compliance to applicable regulations and support through product approvals.
- Prepare and/or advise others on preparation of regulatory submissions for introduction of novel products in accordance with regulatory requirements.
- Establishes and maintains positive customer rapport, while driving solutions to meet business needs. Develops and maintains a strong spirit of partnership.
- Advise business and functional leaders on leaders strategic planning and ensure alignment to business needs.
- Advise on best practices and process improvements for regional or global regulatory affairs and regulatory intelligence.
- Advise on how to influence changing regional or global regulations relevant to all products marketed by K-C. Influence the development of new legislation in a manner favorable to K-C through active participation in trade associations and industry coalitions.
- Advise on regulatory intelligence process.
- Advise and support interpretation of existing regulations and those under development relative to the diverse K-C product range. Subsequently identify and advise on communicating the impact of these regulations to the relevant KC stakeholders. Establish clear communication plans and ensure execution, as assigned.
- Advise on applicability of new or proposed legislation changes on marketed products and the innovation pipeline, communicating these developments to senior Innovation, functional or business leaders. Ability to interpret and adapt theory and textbook concepts into workable solutions for delivery of work.
- Advise, mentor, and support development of regional and global regulatory professionals in accordance with the One K-C behaviors and demonstrate leadership qualities associated with this role for self; may provide informal work direction to others.
- Review risk mitigation plans, as requested.
- May represent Regulatory Affairs on crisis management teams related to compliance or business challenges.
- Conduct due diligence for partnerships, mergers, acquisitions, licensees, etc., as requested.
- Coordinates and manages projects across functions and boundaries to establish operational plans to achieve results and objectives with longer-term effect on business, product or

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