Regulatory Labeling Specialist

Regulatory Labeling Specialist
Job Description
You're not the person who will settle for just any role. Neither are we. Because we're out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a difference. Here, you'll bring your professional expertise, talent, and drive to building and managing our portfolio of iconic, ground-breaking brands. In this role, you'll help us deliver better care for billions of people around the world. It starts with YOU.
Position Purpose:
This position will be responsible for the day-to-day execution of the North America advertising, promotion and commercial labeling process. Incumbent will be responsible for the review and approval of advertising, promotional and product labeling material. Incumbent will support continual improvement initiatives of the labeling process and systems, standard and procedures. This position works closely with Marketing, Legal, Quality and Research and Engineering to deliver timely review and approval of product labeling and claims.
Customers:
Marketing, Legal, Research and Engineering, Product Safety, Quality Assurance, Clinical Affairs, Regulatory Affairs team members, and any K-C group, team, or individual needing labeling-related regulatory services and support.
General Expectations and Accountabilities:

• 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 and eliminate loss.
• Manages self in accordance with the expected behaviors of the Leadership Qualities.
• Implements procedures/processes for managing regulatory records and documents.
• Conducts all communications and transactions with the utmost integrity.
• Maintain awareness of advertising, promotion and product labeling documentation developments and requirements and communicate accordingly.
• Manages regulatory records and documents to meet both internal and external requirements.
• Develops the skills and knowledge to meet specific regulatory requirements. Develops and implements strategies and regulatory systems that support requirements and product labeling processes.

Position Specific Accountabilities:

• Execute day-to-day product labeling, ad/promo, claims review and approvals and ensure compliance with US FDA Medical Device, OTC Drug, Cosmetic labeling regulations and internal standards.
• Support the implementation of new/revised advertising, promotion, product labeling/ claims regulatory requirements.
• Helps maintain systems, procedures to effectively manage advertising, promotional, claims and product labeling review and approvals.
• Ensures that appropriate label content is included and with compliant with applicable in advertising, promotional and product labeling regulatory requirements.
• Identifies continual improvement opportunities and collaborates with cross-functional team member to enable best practices regarding planning, execution for the development of new and changing advertising, promotion, claims and product labeling.
• Support the execution of labeling change management.
• Follows Regulatory Affairs Standards, Procedures, Work Instruction and trains on updates that are compliant with industry standards and regulatory requirements.
• Provide insights to ensure the maintenance and supporting IT Software related to labeling controls systems.

Scope:
The incumbent carries out responsibilities with assistance and direction from their team leader. The incumbent assists in department projects by following processes and procedures within their area of responsibility. Provides support to North America region, interfaces with regulatory associates.
Travel and overtime is expected on an occasional basis to meet workload demands.
This role can be based out of Neenah, Wisconsin or Roswell, Georgia. This role will also have a 20% travel requirement.
Qualifications/Education/Experience Required:
The successful candidate must be detail-oriented and possess strong organizational skills to handle multiple projects, the ability to work well under pressure, excellent oral and written communication skills, good interpersonal skills, and a detailed knowledge of current office practices and procedures. The ability to demonstrate judgment, function as a cooperative team member, organize workload, and set priorities is essential. Ability to work effectively with computer systems and a thorough knowledge of current office practices and procedures, including SAP is essential.
Minimum Qualifications:

• Bachler's Degree or demonstrated equivalent ability and experience including advanced level training
• + 3 years relevant professional experience
• Proficiency in Microsoft applications such as Excel, Word, PowerPoint and SharePoint, and SAP
• Experience with Medical Device, OTC Drug, Cosmetic labeling activities is preferred.

Veterans and members of the Reserve and Guard are highly encouraged to apply.
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.
Additional information about the compensation and benefits for this role are available upon request. You may contact 866-444-4516 or kcchrprod@service-now.com for assistance. You must include the six digit Job # with your request.
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 role is available for local candidates already authorized to work in the role's country only. K-C will not provide relocation support for this role.
#LI-Hybrid
#LI-Remote
Primary Location
USA-WI-Neenah
Additional Locations
No K-C Work Site - WI, USA-GA-Atlanta-Roswell
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time