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COMPANY OVERVIEW:
Balchem Corporation develops, manufactures, and markets specialty ingredients that improve and enhance the health and well-being of life on the planet, providing state-of-the-art solutions and the finest quality products for a range of industries worldwide. Our corporate headquarters is located in Montvale, New Jersey and we have a broad network of sales offices, manufacturing sites, and R&D centers, primarily located in the US and Europe. Founded in 1967, Balchem is a publicly traded company (NASDAQ – BCPC) with annual revenues over $900 million and a market cap exceeding $4.0 billion. The company consists of three business segments: Human Nutrition & Health; Animal Nutrition & Health; and Specialty Products. Balchem employs over 1,400 people worldwide who are engaged in diverse activities, committed to developing the company into global market leadership positions. To learn more about our dynamic, stable and growing company, visit www.balchem.com.
POSITION SUMMARY:
Responsible for regulatory review of various products for Balchem' s Human Nutrition and Performance Gases business units, ensuring compliance and delivering excellent internal customer service. Provide expert guidance to internal stakeholders on regulatory affairs as they relate to Balchem' s product lifecycle management (R&D, market introduction, marketing, post-market activity), contributing to key product stewardship objectives. Work collaboratively with various functions to provide regulatory support and guidance.
ESSENTIAL FUNCTIONS:
- Demonstrate a deep, practical understanding of the regulatory frameworks that pertain to Balchem Human Nutrition and Performance Gas products at all stages of the products' lifecycles. Communicate effectively with Project Managers and business teams about key regulatory requirements, required actions and regulatory-related program costs for new product development and product launch. Support project teams as requested, including providing regulatory updates during new product gating reviews.
- Define the scope and quality of information required to meet global regulatory objectives, including product authorizations and claims of product safety and efficacy. Guide internal stakeholders on their contributions to the flow of information to help ensure completeness and robustness of dossiers that Balchem submits to regulatory authorities. Compile dossiers and manage applications through to completion.
- Manage regulatory authorizations and product registrations for the Human Nutrition and Health and Performance Gases, with the support of Corporate Regulatory Affairs teammates and contractors. Advise internally on requirements, budget and timelines for these activities, and manage related procure-to-pay cycle.
- Conduct regulatory review of product documentation and labels, and other documents to ensure compliance in a timely and effective manner. Provide regulatory review and input in reviewing various marketing materials and work collaboratively with others to understand business needs, including providing regulatory support to the Legal team as part of the claims review process.
- Prepare high quality ad hoc and form regulatory documentation, coordinating with Legal, Corporate Quality, Supply Chain and Customer Service, as necessary. Manage regulatory content related to Human Nutrition and Performance Gases business units on company intranet site.
- Keep current on domestic and international product regulations through channels such as governmental agencies, industry media, trade associations, and through participation in industry events. Advise internal stakeholders of developments that may affect product development, market introduction, or business continuity. As needed, manage projects or represent Corporate Regulatory Affairs in interdisciplinary teams on various projects, and be accountable for progress
- Interact with contacts in global markets, e.g. regulatory contacts in foreign offices, industry groups/experts, or foreign government agencies, to stay current with all relevant product laws. Serve as Balchem liaison to industry stakeholder groups (e.g. American Chemistry Council, Council for Responsible Nutrition, Ethylene Oxide Sterilization Association) in a relevant technical capacity. Keep internal stakeholders informed of developments and actions undertaken by these groups, and initiate internal discussions as needed.
- Coordinate and manage various short- and long-term regulatory projects. Manage regulatory consultants to complete these projects, as necessary. Drive completion of the projects and resolution of the underpinning matters that necessitate the projects. Maintain a well-organized database of regulatory tasks to track deadlines, renewals, and other significant due dates. Keep it up-to-date in real time, and report regularly on status of key initiatives to internal stakeholders.
- Support peers and junior colleagues, mentoring and providing guidance in project management.
REQUIREMENTS:
- Master of Science (MS) degree, preferably in chemistry, biochemistry, food science, toxicology or similar discipline. PhD degree highly desirable.
- 3+ years' experience and training in regulatory affairs
- Detailed practical knowledge of government regulation affecting Balchem's end markets (e.g. food, pesticide).
- Strong skills in reasoning, verbal and written communication, particularly related to translation of technical legal and scientific issues to non-specialist audiences.
- Ability to work independently and collegially with cross-functional and cross-cultural groups; commitment to internal customer service
- Adaptable to shifting priorities, demonstrating excellence in organization and follow-through, project management
- Experience in mentoring/management of peers and subordinates, including via informal (non-reporting) arrangements
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Balchem is committed to a workplace culture that values and promotes diversity, inclusion, equal employment opportunities, and a work environment free of harassment and hostility.
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