Regulatory Affairs Senior Manager at Loparex LLC in Cary, North Carolina

Job Description:

Loparex is the world's leading developer and producer of specialty paper and film release liners. We partner with customers around the globe and enable sustainable performance through our in-depth material science expertise and industry-leading technology portfolio. The company is headquartered in Cary, North Carolina, U.S.A. and has three manufacturing sites in North America (Hammond, WI; Iowa City; IA; Malvern, PA), two manufacturing sites in Europe (Apeldoorn, The Netherlands; Forchheim, Germany), one manufacturing site in India (Silvassa) and one manufacturing site in China (Guangzhou).


We are excited to share we are looking for an experienced Regulatory Affairs Senior Manager to join our team!


In this role, the Regulatory Affairs Senior Manager is responsible for managing the Regulatory Affairs Team globally, providing coaching and developing the team acting as a Player Coach.



PRIMARY JOB DUTIES AND RESPONSIBILITIES:

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  Regulatory Policy: Together with the VP Technology, define and implement Loparex's regulatory affairs policy globally
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  Regulatory Strategy: Develop and implement regulatory strategies that enable the delivery of product innovations and growth of base business
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  Regulatory compliance: Ensure all products placed on market meet relevant national and international regulatory requirements
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  Regulatory Submissions: Independently manage in a timely manner all regulatory submissions including a.o DMF and FDA submissions
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  Regulatory Intelligence: Monitor, collect and interpret regulatory issues, legislations, trends or insight that will impact the business and communicate regulatory risk assessments to the relevant global teams
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  Supplier Data: Develop and maintain process for supplier regulatory data collection and adoption of intelligence authoring processes for compliance statements
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  Customer and Product Regulatory Statements: Develop strategy to quickly respond to customer regulatory requests and provide rapid and accurate customer feedback including product compliance statements
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  Communication and Coordination: Collaborate with multi-functional team including R&D, Marketing, EHS, QA and Sales

JOB SKILLS, EXPERIENCE, AND KNOWLEDGE REQUIREMENTS:

• Bachelor's Degree in Chemistry or Environmental Science
• Minimum 8 years regulatory affairs experience with at least 3 years of people management within regulatory affairs
• Good knowledge of available Intelligent Authoring and Compliance Management software required
• Knowledge of flexible packaging or paper industries preferred
• Excellent organizational skills
• Excellent cross functional and cross cultural communication skills
• Fluent in English with German language an advantage
• Global experience preferred

BENEFITS:

• Medical, Dental, and Vision Insurance
• Health savings account with generous annual employer contribution
• Fitness reimbursement program
• Development and career growth opportunities
• Competitive 401(k) matching program

We are an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other category protected by applicable law. Apply Now