Advisor, Global Regulatory Affairs-Innovation

The Advisor, Global Regulatory Affairs provides vision, direction, and advice in the implementation of Global Regulatory strategies to ensure global management of enterprise or 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, Global Regulatory strategies to manage global innovation and preparation of Global Regulatory submissions 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 Global Regulatory affairs strategies for the innovation center of excellence across the Enterprise.  This position will assess the regulatory impact and risk associated with changing legislation across the globe, and subsequently provide the vision to ensure platforms, programs and innovation activities incorporate these compliance requirements into global innovation, product development and life cycle management to ensure Global Regulatory compliance.

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 Global Regulatory affairs with the Global Innovation Team.
• Develop and execute global, innovative regulatory strategies that will ensure compliance with global regulations.
• Advise on regulatory intelligence, governance, best practices, and process improvements. Support product development activities and in accordance with enterprise or business launch plans
• Prepare and/or advise others on preparation of regulatory submissions for introduction of novel products in accordance with Global Regulatory requirements.
• Establishes and maintains positive customer rapport, while driving solutions to meet business needs. Develops and maintains a strong spirit of partnership.
• Advise on how to influence changing global regulations relevant to all products marketed by Kimberly-Clark. Influence the development of new legislation in a manner favorable to K-C through active participation in trade associations and industry coalitions.
• 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.
• 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.
• Advise, mentor, and support development of 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.
• 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.
• 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.
• Advanced capability to influence internally within two to three levels of role.
• Maintains and demonstrates an expert level knowledge and skill in products, quality systems, processes, and regulations.

• 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 Senior Director Global Regulatory Affairs.

Qualifications:

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

OR

• Education: Master's degree in relevant field
• Experience: 7+ years of prior relevant experience
• Experience in a regulatory product clearance role in a medical device, pharmaceutical, consumer goods, cosmetic, chemical or similar environment achieve market access for finished products for sale in multiple regions or geographies.
• Deep subject matter expertise in Global Regulatory requirements for medical devices, pharmaceutical or cosmetics. Interaction and experience working with Global Regulatory bodies as well as advanced knowledge of market clearance and/or approvals (e.g., US FDA Medical Device 510(k) pre-market approvals; FDA OTC Drug requirements, EU MDR/UKCA; Consumer; Cosmetics; EPA Pesticides/Biocides, NIOSH PPE requirements, skincare, food contact, textile and international regulatory bodies processes for similar product categories).
• Experience with cross-functional early research and new product development teams and coaching through programs for regulatory success throughout the product lifecycle.
• Expert level technical and subject matter expertise in product regulatory requirements and executing complex regulatory strategies. Provide regulatory guidance to achieve business outcomes.
• 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.
• Experience with industry trade associations, regulators, and strategic customers.

Preferred Qualifications:

• A Master’s degree in Sciences, Business, Engineering, Operations, 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 global organization.
• Exceptional leadership skills and passion for technical regulatory expertise and regulatory excellence. Leading in complex, technical analysis and discussions related to product regulatory affairs. 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’s growth agenda.
• Recognized in the industry as a regulatory professional.
• Experience being responsible for the execution of regulatory registrations, pre-market approvals, and management of complex regulatory environment for multiple businesses/regions.

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