Dietary Supplement Compliance Manager

For the past 162 years, Swisher has been an industry leader known for its iconic products and commitment to high quality standards. With a rich history, Swisher serves adult consumers through a diverse range of businesses, including Swisher Sweets Cigar Company, Helme Tobacco Co., Hempire, Rogue Holdings, and Drew Estate: The Rebirth of Cigars. We have a passion for people and helping them build rewarding careers. If you’re ready to create excitement and drive what’s next in the industry, we’d love to hear from you.
The Dietary Supplement Compliance Manager plans, develops and executes regulatory compliance strategies and initiatives. The role develops and implements processes, systems, protocols and programs to address regulatory requirements applicable to the Company’s products and operations. This role also works with internal and external stakeholders, including federal, state and international regulators, to support regulatory compliance, business continuity and new product development.

Key Responsibilities

Supports regulatory compliance for dietary supplements and other non-tobacco consumer products, including product classification, formulation and ingredient review, labeling, claims, manufacturing requirements and post-market compliance
Reviews product concepts, formulations, ingredients, labels, marketing materials and proposed claims for compliance with applicable FDA requirements
Works with Quality, Operations, R&D, Marketing and other internal stakeholders to establish and maintain appropriate compliance processes for dietary supplement products
Monitors changes in applicable laws, regulations, FDA guidance and enforcement activity and recommends appropriate Company actions
Manages or supports, as assigned, regulatory compliance initiatives, including collection and analysis of relevant facts, data, scientific information, research and prevailing practices
Assesses the impact of regulatory requirements and assists in developing and implementing appropriate compliance responses
Assists in preparing communications, notifications, registrations and submissions to FDA and other applicable federal and state authorities
Supports development and review of scientific and other data necessary to substantiate product safety, regulatory compliance and product claims
Develops and maintains knowledge of applicable regulatory requirements across relevant consumer product categories and provides advice regarding the production, marketing and sale of such products
Supports manufacturing compliance oversight in conjunction with Operations and Quality, including applicable dietary supplement current Good Manufacturing Practice requirements

Qualifications

Bachelor’s Degree with at least 5 years of relevant experience in program management, data collection and analysis, drafting detailed reports and analyses, business planning, and research planning
Excellent written and oral communication skills
Demonstrated ability to recognize and interpret changes in the regulatory environment and identify appropriate compliance and business responses
Excellent interpersonal and decision-making skills. Persuasive, effective and flexible in personal interactions at all levels
Knowledge and understanding of the Federal Food, Drug, and Cosmetic Act and applicable FDA regulatory requirements, guidelines, laws and regulations, with the ability to interpret and apply regulatory requirements to specific classes of marketed products and product development activities. Experience with tobacco product regulation is a plus
Demonstrated knowledge and experience with dietary supplement requirements under the Federal Food, Drug, and Cosmetic Act and applicable FDA regulations and guidance, including labeling and claims, current Good Manufacturing Practices under 21 CFR Part 111, ingredient and New Dietary Ingredient requirements, and post-market compliance obligations

Preferred Qualifications

Bachelor’s Degree and at least 5 years of relevant regulatory, compliance or related experience, including experience in one or more of the following areas: chemistry, toxicology, biology, psychology, or other relevant scientific areas
Knowledge/experience working in or advising regarding regulatory science.
Ability to understand, analyze and manage scientific issues/programs.
What we offer
Base salary and bonus program
Medical, dental, vision, life insurance effective on date of hire
Generous 401(k) Plan
Defined Contribution Plan
Paid vacation and paid holidays
Tuition reimbursement
Professional growth and development programs to help advance your career!
Official Contact Information
Email:
All official emails will come from an @Swisher.com address
Website:
Verify job listings and contact details on
<https://careers.swisher.com>
Phone:
Call our main number listed on
<Swisher.com>
for verification
Important:
We will never contact you via Teams, Zoom, or Google Meets. If you qualify for an interview, the proper meeting method will be shared with you beforehand. Confidential information should only be shared through secure methods outside of email.