Job Description

APAC Regulatory Affairs Product Manager

Expectations and Accountabilities:

• Actively monitor the evolving regulatory landscape and proactively communicate potential business impact to management
• Develop KCP presence in industry groups to facilitate our organizations ability to shape the regulatory landscape
• Develop and implement domestic, regional, product specific regulatory strategies in support of business objectives.
• Prepare accurate right first time regulatory submissions to secure timely approvals in support of business initiatives
• Engage commercial and functional stakeholders on progress of regulatory initiatives and proactively communicate risks and present mitigation plans
• Provide an interpretation of regulatory requirements, both domestic and regional to the appropriate business team members and highlight implications of differences with respect to product development and testing activities so as to minimize overall development activities while bringing speed to the registration process.
• Conduct training seminars on domestic and regional regulatory requirements and/or impending regulations to the appropriate business team members to enable the best development activities.
• Implement and maintain systems to ensure accurate, complete and timely submissions to regulatory agencies
• Anticipate and assist in the resolution of regulatory and/or quality issues and recommends corrective action
• Provide guidance to departments or development project teams regarding design, development, evaluation (e.g., bench testing, human use studies), or marketing of products to ensure regulatory requirements are met.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures and affected K-C business units.
• Uses relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards and provide an interpretation of regulatory requirements to the appropriate business team members.
• Provide leadership to ensure that regulatory submissions as appropriate are prepared and submitted accurately, completely and in a timely manner to meet business objectives, consulting with regulatory agencies as appropriate for clarification.
• Demonstrates one K-C behaviors in all business interactions to ensure that the GRA team attracts, develops and retains the best people, and fosters an environment which motivates a diverse team to fully use its capabilities in achieving desired business results.

Scope: This role reports to Associate Director, KCP APAC Regulatory Affairs. He/she provides direction, advice and assistance to the organization\xe2\x80\x99s facilities, business sectors and team members on regulatory compliance and knowledge management. The role is responsible for maintaining regulatory management systems designed to effectively and efficiently support business objectives. This individual provides analytical, interpretive and evaluative solutions to complex problems through specialized quality and regulatory expertise based on an in-depth knowledge of technical and business practices. This role integrates and coordinates activities within clearly defined policies; helps develop and champion regulatory policies; relies on an ability to understand and motivate people without direct authority; and is responsible for providing services to client business units. Qualifications/Education/Experience Required:

• A broad technical background is required; preferably a graduate level degree, or as a minimum, a bachelor\xe2\x80\x99s degree in a major scientific discipline, preferably pharmacy, chemistry, or microbiology.
• Minimum of 5 years of relevant regulatory technical experience in skincare products (hand sanitizers/hand cleansers), including direct experience in submissions, regulatory defense, and product life cycle management within the Asia Pacific region.
• Expertise in the various regulatory framework covering skincare products (hand sanitizers/hand cleansers) across Asia Pacific with key focus on China, India, ANZ, and ASEAN. Proven track record of registering skincare products (hand sanitizers/hand cleansers) across Asia Pacific.
• Excellent understanding of key US and EU disinfectant and medical device regulatory framework eg Medical Device Regulation, REACH Regulation, CLP Regulation, EPA regulations, Biocidal Product Regulation (EU) 528/2012 and other relevant guidance documents. Ability to articulate the impact of these regulations to Asia Pacific.

Primary Responsibilities:

• Participate on project teams developing/launching new products by defining regulatory requirements and develop regulatory strategies and/or complete assessments to ensure compliance and successful achievement of business objectives.
• Establish and maintain an information network for purposes of monitoring and maintaining a current knowledge base of existing emerging regulations, standards, and guidance documents, followed by appropriate preventive communication and training within the K-C business units.
• Prepare responses to APAC regulatory authorities for disinfectants and medical device product inquiries and reporting obligations.
• Provide advice and counsel to staff and regional manufacturing facilities regarding compliance with APAC Quality system and GMP/GDP requirements, as well as international and national standards, when necessary.
• Establish and maintain a process to participate in the review of process/product changes, labeling, claims, complaints, etc., to ensure compliance to internal QMS, APAC regulatory and international requirements and provide notification to regulatory authorities as required.
• Serve as a liaison for GRA internally with GPS, GCA, business quality assurance units, legal and other regulatory resources as well as externally with the regulators and/or health ministries.
• Write or update standard operating procedures, work instructions, or policies as appropriate
  
  #LI-Hybrid

Global VISA and Relocation Specifications:

Primary Location

Malaysia - Petaling Jaya

Additional Locations

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time