Regulatory Affairs Specialist (Manufacturing)
Recognized as a Best Places to Work in Vermont for the fifth year in a row, New Chapter is a certified B-Corp, and an Organic, Non-GMO and certified Gluten Free manufacturer of dietary supplements that places our employees and our consumers first. We are a wholly owned subsidiary of Procter & Gamble. We invite you to discover a new chapter in your career, and in your life, by considering this opportunity to join our team! We strongly encourage applications from diverse communities across race, gender, sexual orientation, religion, ethnicity, national origin, and other marginalized communities.
ROLE PURPOSE: The Regulatory Affairs Specialist will provide timely and effective regulatory knowledge and expertise in support of New Chapter formulations, New Chapter marketed products, and other initiatives.
MAJOR ROLE ACCOUNTABILITIES:
- Maintain regulatory compliance via a demonstrated knowledge of FDA and global regulations and effective management of regulatory deliverables with regards to both current and new products.
- Provide regulatory expertise to cross-functional teams, including but not limited to attendance at technical project and team meetings, and review of Change Controls for new products or updates to existing products.
- Ability to identify, plan, and execute regulatory deliverables such as review of raw materials, documentation of regulatory assessments, preparation of regulatory sheets, and labeling reviews, involving cross-functional team members as required.
- Manage or aid in the preparation of correspondence with regulatory agencies, including but not limited to structure/function claim notifications, Certificates of Free Sale, NDI's.
- Collaborate with Product Safety and/or Quality functions to provide aligned governance perspective.
- Support International initiatives as assigned, including but not limited to UAE product registrations and/or Health Canada.
- Monitor new and changing regulations landscape pertaining to the FDA, Prop 65, UDSA, FTC, etc.
- Maintain Purchase Orders in ERP system.
- Effectively manage tasks and workflows in Veeva systems (Veeva PromoMats, Veeva QualityOne).
- May include support for third-party certifications, assessments to support self-declarations, product claims review, or other tasks as assigned.
KEY COMPETENCIES:
- Strong attention to detail, and willingness to conduct in-depth research to understand and apply complex regulations.
- Strong written and verbal communication skills.
- Ability to manage multiple and shifting priorities with high degree of accuracy and organization.
- A self-starter with the ability to work independently to execute regulatory deliverables.
- Must possess collaboration skills to work with others on project teams and other cross-functional teams.
- Demonstrated knowledge and application of FDA and other applicable regulations.
- Understanding of global regulations and/or willingness and ability to support international projects as needed.
EXPERIENCE, EDUCATION and CREDENTIALS:
- BS in Scientific Discipline, Regulatory Affairs, or other similar area(s) of study, and/or 1-2 years previous experience in a Regulatory Affairs and/or Quality Compliance role required
- Prior experience in dietary supplement or food industry preferred
This is a hybrid position based in Southern Vermont
New Chapter is an equal opportunity employer
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
