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Sr Business Analyst, Global Regulatory Affairs at Kimberly-Clark Corporation

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Roswell, Georgia





Job Description:

Sr Business Analyst, Global Regulatory Affairs

Job Description

Sr Business Analyst, Global Regulatory Affairs

Location: Neenah, WI or Roswell, GA

SUMMARY OF POSITION:  

The Sr Business Analyst, Global Regulatory Affairs brings subject matter expertise, regulatory experience and best practice knowledge to lead the technical development and implementation of specific areas of the Kimberly-Clark global regulatory affairs processes and associated IT systems. Provides partnership, direction, and guidance to the K-C business community to ensure that regulatory affairs goals are met through the effective provision of advanced technology solutions and services. Provides oversight and guidance to enable the successful delivery of end-to-end digital tools.

ESSENTIAL ACCOUNTABILITIES:


  • Accountable to ensure all elements of Global Regulatory Affairs are considered during the Digital Transformation requirement gathering, system design, and implementation.

  • Ensures existing regulatory affairs system interfaces are identified and designed appropriately into the new solution(s). Consider global activities and requirements.

  • Liaison with the global regulatory affairs team to ensure current standards are well understood and integrated into regulatory systems and digital tools.

  • Develops standardized system approaches aligned with industry best practices in regulatory affairs.

  • Supports the creation of systems and tools to add global efficiency and data sharing.

  • Maintains comprehensive knowledge of applicable regulatory requirements and interpretation.

  • Provides regulatory compliance expertise by sharing external regulatory environment, industry trends as well recommending actions to address any potential impact to the enterprise.

GENERAL EXPECTATIONS AND ACCOUNTABILITIES:


  • Manage self in accordance with the expected One K-C Behaviors.

  • Influence and recommend new quality concepts, tools and strategies for the enterprise Quality organization.

  • Builds capability in self by maintaining and demonstrating a high degree of knowledge and skill in quality management systems, processes, and regulations.

  • Builds and maintains strong relationships and networks with key stakeholders and peers within the business unit, across the enterprise, and across industry.

  • Establishes and maintains collaborative relationships while driving solutions to meet business needs.  Develops and maintains a strong spirit of partnership.

  • Conduct all communications and transactions with the utmost integrity, consistent with the KC Code of Conduct.  Communicate effectively with Senior Leaders, Peers, Functional Partners.

  • Provide strategic thought leadership for the build and management of complex, end-to-end QRC business process solutions to help drive compliance across digital systems with wide range of complexity.

  • Experience working with blended teams consisting of employees, vendors, and consultants with both onshore and offshore resources.

  • Excellent written and verbal communication skills along with strong desire to work in cross functional teams.

  • Possess strong leadership skills and exhibit creative thinking to be able to come up with inventive solutions to solve business challenges.

  • Provide thought leadership while keeping up with industry trends and disseminating information across the organization.

  • Familiar with the technology landscape for End-To-End Product Lifecycle and where the QMS elements fit along that path.

  • Ability to work in a virtual team which may work across distance (remote), cultures and time zones, in a matrix with multiple reporting lines, and may extend outside the K-C organization including suppliers, partners and customers.

  • Role is based at the K-C location in Roswell, GA or Neenah, WI USA.

BASIC QUALIFICATIONS:


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

  • 5+ years of experience in a regulatory affairs role in a medical device, pharmaceutical, cosmetic or similar environment.

  • Proven ability to communicate in written and spoken English.

PREFERRED QUALIFICATIONS:


  • A minimum of 5 years developing and deploying, efficient and effective regulatory affairs processes, preferably across multiple geographic regions.

  • Experience in an organization with regulatory affairs as a compliance function. Experience with company controls for global regulatory submissions and associated data. Experience with a Regulatory Information Management system and Document System helpful.

  • Demonstrated understanding of Medical Devices, Consumer Products, and/or Cosmetic regulations across the globe.

  • Thorough understanding and experience interfacing with regulatory bodies across all regions.

  • Demonstrate understanding and impact of industry trends, emerging regulatory compliance requirements and best practices via internal/external benchmarking for integration considerations into business specific quality strategies. Gather and articulate global requirements.

  • Understanding of key regulations and standards applicable to K-C specifically related to medical devices as a consumer product or other highly regulated products.

  • Is able to influence and engage at varying levels of the organization.

  • Training system development and/or management

  • Experience working in quality systems where these regulations and guidelines are followed.

  • Understands and can apply industry-standard practices such as Good Manufacturing (GMP).

  • Ability to anticipate and meet deadlines, handling multiple simultaneous deadlines, prioritizing work, strong attention to detail, and the ability to retain confidential information.

  • Collaborative, responsive, action-oriented and innovative problem solver.

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:

K-C will support in-country relocation for the chosen candidate for the role, including assistance to obtain proper work authorization. The benefits provided will be per the terms of K-C’s applicable mobility policies. The benefits/policy provided will be decided in K-C’s sole discretion.

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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