Job Description

Advisor, Regulatory Affairs - APAC



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.
• Recognized in industry as a thought leader. Recognized as subject matter expert within business and enterprise. Based on role, will have experience with industry trade associations, regulators, and strategic customers.
• 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 function.
• Agency and topic area expert level SME internally with responsibility to external opportunities with agencies, Industry Associations and/or working groups.
• Support and/or lead challenging communication situations internally or with external agencies/regulators to ensure business outcomes.
• Identifies issues, creates plan to address and enlists others to support to resolution. Advanced capability to influence internally within two to three levels of role.
• Promote and support continuous improvement activities for established processes and development of new processes.
• Maintains and demonstrates an expert level knowledge and skill in products, quality systems, processes, and regulations.
• Influence and support product stewardship activities, may represent RA on Product Stewardship councils, as needed.

• Manages self in accordance with the expected One K-C Behaviors commensurate with Role (Sr Manager).
• Conducts all communications and transactions with the utmost integrity, consistent with the K-C Code of Conduct.

• Perform other tasks and activities as assigned by the Regulatory leadership.

Role is based out of the China, Malaysia, Mumbai or Singapore K-C Office.

QUALIFICATIONS

Basic Qualifications

• Education: Bachelor\'s degree in Business, Engineering, Operations, or equivalent degree.
• Experience: 10+ years of prior relevant experience

OR

• Education: Master\'s degree in relevant field
• Experience: 7-10 years of prior relevant experience
• Experience in a regulatory role in a medical device, pharmaceutical, industrial, chemical, consumer goods, cosmetic or similar environment.
• Deep subject matter expertise in APAC regulatory requirements for medical devices, pharmaceutical, industrial, chemical, consumer goods, and/or cosmetic. Interaction and experience working with global regulatory bodies as well as working knowledge of pre-market approvals (e.g., TGA-Aust, China-MOH, NHC, Malaysia (DOSH SIRIM, NPRA, MDA), Thai-FDA , Bureau of standards (certs, Food contact) TIIS, India-CDSCO, international regulatory bodies).
• Demonstrated leadership experience within a complex, matrix or multi-business organization.
• Advanced, compelling communication skills. Ability to communicate at all levels of the organization and managing through complex compliance challenges to successful resolution.
• Advanced ability to work across functional & technical boundaries without hesitation.
• Expert level knowledge functional and technical expertise.
• Works independently with strategic direction for activities in areas of expertise and responsibility.
• Advanced capability business acumen and strategic planning.

Preferred Qualifications

• A Master\xe2\x80\x99s degree in Science, Engineering, Business, or equivalent degree.
• Experience in an organization with Quality and Regulatory Affairs as a compliance function.
• Experience advising or leading a multi-business or multi-region regulatory affairs teams in a regional or global organization.
• Exceptional leadership skills and passion for technical regulatory expertise and regulatory excellence. Strong track record of delivering complex, innovative regulatory strategies and executing to successful outcomes.
• Experience building capability in a Regulatory Affairs team and other functions. Proactively manages regulatory requirements while also supporting the organization\xe2\x80\x99s growth agenda.
• Recognized in the industry as a regulatory professional.
• Experience being responsible for the execution of regulatory registrations, clearances, notifications, and management of complex regulatory environment for multiple businesses, countries, or regions.

Primary Location Singapore

Additional Locations Beijing Mill, India - Mumbai, Malaysia - Petaling Jaya

Worker Type Employee

Worker Sub-Type Regular

Time Type Full time

Kimberly-Clark