Posted in General Business 9 days ago.
Regulatory Affairs Manager - NA KCP
Provide technical leadership in the development and implementation of regulatory strategies to support the achievement of global business objectives for client K-C business units, while ensuring compliance with national, regional and international regulations. Provide vision and direction to specific business sectors concerning global market strategies and tactics as well as growth opportunities for existing categories.
The primary customers are the Global and Regional NA KCP Businesses. Other customers include; mill/plant operations and quality management teams, R&E, Legal, Global Regulatory Affairs, Global Quality Assurance, Global Clinical Affairs, Global Product Safety, Purchasing, Logistics, suppliers and contract manufacturers.
Expectations and Responsibilities:
The incumbent enables market access for KCP PPE & MD including specifically mask and respirator products including those regulated by NIOSH, US FDA & Health Canada by developing knowledge of the regulations / import restrictions and developing and implementing strategies and processes for getting products to market in a timely and cost-effective manner.
The incumbent is responsible for establishing and maintaining harmonized global regulatory management systems designed to effectively and efficiently support global business objectives.
This individual provides analytical, interpretive and evaluative solutions to complex problems through specialized regulatory expertise based on an in-depth knowledge of technical and business practices. The incumbent integrates and coordinates activities within clearly defined policies; develops and champions regulatory policies; relies on an ability to understand and motivate people without direct authority; and is responsible for providing services to client business units.
The main challenges of the position are:
A Bachelor´s degree in a relevant discipline and 8+ years of relevant technical experience, or 10+ years of relevant technical experience. Experience should include close working relationships with Business, Marketing, Manufacturing and Research functions, and a solid background of technical knowledge and experience combined with the proven ability to successfully direct projects and influence people at all organizational levels. Minimum of 5 years’ experience with PPE is required, including experience with NIOSH & US FDA regulated PPE. Must be fluent in English, other languages are desirable.
Ensure participation in project teams developing/launching new products to define global, regional and national PPE regulatory requirements and develop regulatory strategies and assessments to ensure successful achievement of KCP business objectives.
Establish and maintain a process and provide leadership to the businesses to ensure that regulatory documentation (e.g. NIOSH & FDA submissions) are prepared accurately, completely and in a timely manner, submitted to regulatory authorities, and updated and maintained in accordance with regulatory requirements and business objectives.
Establish and maintain an information network for the purposes of monitoring national, regional and international PPE test method developments, and ensuring proactive preventive communication and training within the K-C business units.
Provide advice and counsel to businesses and global manufacturing facilities regarding compliance with regulatory GMP and quality requirements, as well as international and national standards, when necessary.
Provide consultation and guidance relative to the resolution of regulatory and/or quality issues and non-compliances.
Establish and maintain a process to participate in the review of process/product changes, labeling, claims, complaints, etc., to ensure compliance to internal and international requirements and provide notification to regulatory authorities as required.
Serve as a liaison for GRA internally with GPS, GCA, legal and other regulatory resources as well as externally with notified bodies, certification agencies, regulatory authorities, trade associations and consulting organizations.
Represent Kimberly-Clark’s interests at Trade Associations as required, lobby to ensure that impacts of changes to regulations that could be detrimental to K-C’s business interests are minimized.
Provide leadership and coaching to ensure that GRA attracts, develops and retains the best people, and fosters an environment which motivates a diverse team to fully use its capabilities in achieving desired business results.
Perform other tasks and activities as directed by the Associate Director GRA/Director GRA.
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.