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Our Company

Bonafide Health (www.hellobonafide.com) is a rapidly growing, innovative healthcare company focused on developing scientifically validated, powerful supplements and medical devices to treat women's common healthcare needs and improve their quality of life. Our mission at Bonafide is to provide women with new and effective options for relief throughout their menopause journey. Trusted by more than 15,500 unpaid healthcare professionals, our portfolio of drug- and hormone-free options is rigorously researched and validated through dozens of clinical studies. We aim to be the go-to resource for women seeking educational resources about menopause and symptom management while continuing our mission of providing women with innovative, safe, and effective solutions for menopause relief from hot flashes and vaginal dryness to improve sexual satisfaction.

Our People

Our growing team is composed of highly experienced scientists, marketers, and eCommerce professionals, as well as recent graduates, making Bonafide a dynamic and exciting place to work and learn. Our people are talented, motivated, and aim to get better each day. Every one of us is expected to be a leader, a teammate and to demonstrate passion in all that we do.

Job Description

Bonafide is looking for a talented and passionate Regulatory Manager who will report directly to the Senior Director of Quality and Regulatory. The Regulatory Manger will work on the generation of product labels and product communications, documentation, regulatory submissions and other regulatory related activities. This individual's responsibilities include but are not limited to the following:

Responsibilities

• Review product formulas and raw materials for compliance with applicable regulatory requirements.
• Analyze nutrition information and help generate new and updated product labels including food/supplement facts panel, ingredient statements and allergen statements ensuring compliance with regulations.
• Review and approve label artwork, graphics and text with a high level of detail for accuracy.
• Identify labeling issues and concerns and communicate with the appropriate teams.
• Maintain label records and regulatory documentation.
• Support documentation management of product nutrition and ingredient information as well as related supporting documents from vendors.
• Manage label change control process, ensuring timely reviews and approvals by key stakeholders.
• Assist with the development of specifications for ingredients and products.
• Contribute to product related communications with regulatory and nutrition insights.
• Collaborate with multiple functions and support innovation projects.
• Monitor US and global regulatory legislation and provide the team with regular updates.
• Assist with the implementation of programs, policies, SOPs and practices to ensure products comply with appropriate regulations.
• Support regulatory submissions as required.
• Provide regulatory guidance and assist the QA Technical Customer Services team on customer inquiries related to finished product.
• Support end-to-end teams with new product development.
• Review and manage the submission of finished product claims to the FDA.

Requirements

• B.S. degree in pharmacology, biochemistry, chemistry, biology, or related field, or comparable experience.
• 5 years in a regulatory role.
• Hands on experience with US FDA labeling of dietary supplement products, consumer food packaged goods or related industry.
• Experience writing and reviewing standard operating procedures (SOPs).
• Ability to interpret and implement regulations and guidance documents.
• Experience managing FDA 510(k) submissions a plus.
• Experience with FDA and CFSAN a plus.
• Proficient in Microsoft Word, Excel, and other MS office programs, etc.
• Strong interpersonal and organizational skills.
• Excellent technical skills.
• Ability to problem solve, multitask and work under pressure to meet deadlines.
• Ability to work independently.
• Analytical and attention to detail is critical.
• Ability to manage complex information and multiple priorities.
• Collaborative and results oriented.
• Customer focused.

Compensation & Benefits

• - as well as peace of mind.
• Comprehensive insurance and benefits package, including health, vision, and dental.
• 401K plan participation yearly company match.
• Flexible Time Off (exempt employees)

Annual Pay Range $79,500 - $119,300 7% bonus target

This represents the minimum and maximum base salary range for this role, plus annual incentive. Various elements are used to determine a candidate's starting salary such as job experience, specific skills, and comparison to internal incumbents currently in the role. This information is provided to applicants in accordance with state and local laws.

Location and Work Model

Bonafide Health headquarters are in Harrison, New York, which is in Westchester County, approximately 22 miles north of Manhattan. Our team is operating in a hybrid work model and this role will have the flexibility to work remotely part of the time and in our physical office as needed.

Equal Employment Opportunity

Bonafide is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status.