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Global Regulatory Intelligence Program Lead at Kimberly-Clark Corporation

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Roswell, Georgia





Job Description:

Global Regulatory Intelligence Program Lead

Job Description

SUMMARY OF POSITION: 

The Global Regulatory Intelligence Program Lead is responsible for the management of the Global Regulatory Intelligence program and coordinating with other groups within Kimberly-Clark (K-C) to meet the business objectives for advocacy, trade associations, and industry presence. Serves as Global regulatory policy and intelligence contact for key internal and external stakeholders to further K-Cs priorities. Provides guidance to business and functional leadership for governance, monitoring and influencing on a global level.

This role reports directly to the Director, KCP Regulatory Affairs & Global Reg Intelligence.

ESSENTIAL ACCOUNTABILITIES:


  • Responsible for setting the strategic direction for Regulatory Intelligence Programs and Compliance for Global Regulatory Affairs (GRA).


  • Responsible for managing, assessing, and improving processes to fully implement the Regulatory Intelligence compliance program.


  • Assist in the development of policies, standards, procedures, and guidelines to align with corporate risk appetites, tolerances and policies for regulatory affairs.


  • Research, collect, organize, and maintain files on regional and global regulatory intelligence and other related information.


  • Apply recognized methodologies and tools to conduct intelligence analysis and profiling to identify emerging compliance risks and opportunities.


  • Promote an intelligence culture that supports a targeted approach to compliance.


  • Engage and develop tactical/operational partnerships to enhance the building and sharing of intelligence.


  • Foster relationships and build bridges across functions, regions, and business.


  • Manage the compilation of accurate and timely intelligence and drive implementation of change actions based on the analysis of intelligence. This will include using and developing appropriate information and intelligence. analysis methodologies and processes to support delivery of the objectives that align with K-C priorities.


  • Create and chair a cross-functional team that defines and oversees the standardization and implementation of systems/processes to monitor the regulatory environment for changes that may have an impact on K-C’s products and goals within global regulatory affairs.


  • Maintain relationships with industry peers and regulatory bodies, as applicable.


  • Identify, respond and/or escalate risks as appropriate.


  • Support regulatory affairs personnel or, as requested, direct project teams in the ongoing development and implementation of strategic plans and objectives, and regulatory changes.


  • Develop formal process for submitting K-C comments to agencies or regulatory authorities.


  • Supports enterprise initiatives to drive internal and external engagement on key global priorities to enable measurable impact across the enterprise.


  • Review representation of K-C in internal and external working groups and technical initiatives, make recommendations and/or establish tracking processes.


  • Develop white papers and presentation slides outlining policy positions and strategy.


  • Communicate impact of work with business mindset.


GENERAL EXPECTATIONS AND ACCOUNTABILITIES:


  • Promotes and demonstrates safety as a value by performing all job functions safely while also complying with corporate policies and departmental procedures in an effort to reduce risk, ensure consumer safety and eliminate loss.


  • Manages self in accordance with the expected One K-C Behaviors commensurate with Role (Sr Professional).


  • Develops and administers quality organizational feedback, culture or accountability and other management tasks (onboarding, training, talent management, etc.).  Provides feedback, coaching and work direction to team leaders and team members.


  • Maintains and demonstrates a high degree of knowledge and skill in product form and quality systems, processes and regulations.


  • Establishes and maintains positive customer rapport, while driving solutions to meet business needs. Develops and maintains a strong spirit of partnership.


  • Conducts all communications and transactions with the utmost integrity, consistent with the K-C Code of Conduct. 


  • Promote and support continuous improvement activities for established processes and development of new processes.


Role is based out of the Neenah, WI or Roswell, GA K-C Office.

BASIC QUALIFICATIONS:


  • A Bachelor’s degree in Business, Engineering, Operations or equivalent degree.


  • 7+ years of experience in a regulatory role in a medical device, pharmaceutical, consumer goods, cosmetic or similar environment.


  • Deep subject matter expertise in regulatory compliance requirements for medical devices, pharmaceutical or cosmetics. Interaction and experience working with various regulatory bodies across the globe as well as working knowledge of pre-market approvals (e.g., US FDA Medical Device 510(k) pre-market approvals; FDA OTC Drug requirements; Consumer; Cosmetics; EPA Pesticides/NIOSH PPE requirements).


  • Experience directly interfacing with North America regulatory bodies such as Health Canada and FDA.


  • Demonstrated management experience within a complex, matrix or multi-business organization.


  • Ability to communicate at all levels of the organization and managing through complex compliance challenges to successful resolution.


PREFERRED QUALIFICATIONS:


  • A Master’s degree in Business, Engineering, Operations or equivalent degree.


  • Experience in an organization with Quality and Regulatory Affairs as a compliance function.


  • Experience leading a multi-business or multi-region regulatory affairs project or process in a global organization.


Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, 1.3 billion people - nearly a quarter of the world's population - trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With more than 140 years of history of innovation, we believe in recruiting the best people and empowering them do their best work.  If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark.  

For Kimberly-Clark to grow and prosper, we must be an inclusive organization that applies the diverse experiences and passions of its team members to brands that make life better for people all around the world.  We actively seek to build a workforce that reflects the experiences of our consumers.  When you bring your original thinking to Kimberly-Clark, you fuel the continued success of our enterprise. We are a committed equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, age, pregnancy, genetic information, citizenship status, or any other characteristic protected by law.

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

This position may require a post-offer/pre-hire Physical Abilities Test (PAT) to confirm that individuals are able to perform the essential functions of the job. 

K-C requires that an employee have authorization to work in the country in which the role is based.  In the event an applicant does not have current work authorization, K-C will determine, in its sole discretion, whether to sponsor an individual for work authorization.  However, based on immigration requirements, not all roles are suitable for sponsorship. This position is subject to drug and alcohol testing, including pre-employment testing.
 

Global VISA and Relocation Specifications:

Primary Location

USA-GA-Atlanta-Roswell

Additional Locations

USA-WI-Neenah

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





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