The Sr Regulatory Affairs Associate, Import & Export supports the Global Regulatory Operations programs to develop product regulatory market entry strategies for new and existing products in all countries of Launch. This position will focus on providing support and expertise for the development and implementation of processes for regulatory activities including coordination of import and export activities that support international product registrations. This individual contributor will work closely with trade associations such as PCPC and regulatory agencies such as the US Food and Drug Administration to obtain the appropriate certificates, notarized, and apostilled documents necessary for regional regulatory product registrations.
The role reports to the Sr. Regulatory Operations Manager and is responsible for establishing and maintaining harmonized global import and export regulatory management systems designed to support global and regional objectives effectively and efficiently. The incumbent will also assist in department projects by identifying processes and procedures within their area of responsibility.
The incumbent 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 regulatory support services to regional regulatory teams.
ESSENTIAL ACCOUNTABILITIES:
Responsible for systems and processes for global regulatory operations and supporting procedures.
Responsible for the development and maintenance of import and export regulatory programs to ensure compliance with applicable regulatory requirements.
Management of Regulatory Import/Export Information System/Technical documentation database required for regulatory submissions
Support activities related to regulatory import/export documentation including Power of Attorney (POA’s), Certificates of Free Sale, etc. document creation and management to effectively register products
Manage Certificate of Free Sale (COFS) requests and work with the Personal Care Products Council (PCPC) when registration documentation has been requested for Cosmetics and Over the Counter (OTC) drug products for export from the U.S.
Lead U.S. Food and Drug Administration (FDA) Certificate to Foreign Government (CFG) requests using FURLS/CECATS for Medical Device products for export from the U.S.
Work with Texas Department of State Health Services to obtain Certificate of Free Sale (COFS) for a consumer product for export from the U.S.
Role will also include Canadian import/export registration and certificate management.
Establish and maintain a system for US FDA Establishment and Device listing and Health Canada Establishment and licensing requirements to ensure compliance with governmental agency expectations.
Partner with service providers to complete legalization for international product registration documents that require notarization and apostille.
Responsible for Import/Export regulatory management system governance processes and regulatory data management (systems, tools, records and standards).
Manage Import/Export documents using the ETQ Legislative and Regulatory Affairs Module to ensure effective records management and retention of registration records.
Establish and maintain procedures and work instruction related to Import/Export.
Monitor evolving processes and regulatory activities for Import/Export.
Ensures activities and projects are in compliance with both company regulatory standards and applicable government regulations.
Develops the skills and knowledge to manage import/export registration documents for different product types and country-specific registration requirements.
Manage and prioritize project support requests related to import and export certificates in support of regional product registration activity.
Develops and implements strategies and regulatory systems that support continual improvement of regulatory procedures and process.
Developing operational solutions by solving work problems. Conducting gap analysis on standard practice to ensure compliance measures are included.
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 processes and regulations.
Builds and maintains strong relationships and networks with key stakeholders and peers within the function and business unit.
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 Peers & Functional Partners.
Experience working with blended teams consisting of employees, vendors, and consultants with both onshore and offshore resources.
Strong written and verbal communication skills along with strong desire to work in cross functional teams.
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.
Demonstrate 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.
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.
3+ years of experience in a regulatory operations or affairs or compliance focused role in a medical device, pharmaceutical, cosmetic or similar environment.
Proven ability to communicate in written and spoken English.
Demonstrated proficiency in working within SAP database environments and Microsoft programs (Outlook, Excel, Word, PowerPoint, Visio, Project, etc.).
Demonstrated ability to effectively communicate and independently manage multiple tasks in a cross-functional corporate setting and the ability to effectively communicate in written or oral presentation formats.
PREFERRED QUALIFICATIONS:
A minimum of 2 years supporting the development and deployment of 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 and Cosmetic regulations across the globe.
Basic understanding and experience interfacing with regulatory agencies.
Demonstrate understanding and impact of industry regulation. Gather and articulate global requirements, as needed.
Understanding of key regulations and standards applicable to K-C specifically related to medical devices or other highly regulated products.
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 problem solver.
The incumbent must be detailed-oriented and possess strong organizational skills to handle multiple projects, the ability to work well under pressure, excellent oral and written communication skills.
The ability to demonstrate judgment, function as a cooperative team member, organize workload, and set priorities are essential.
Ability to work effectively with computer systems, regulatory agency, and trade association databases.
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.
