We inspire a trust in plants and respect for nature. We balance purpose with profit, treating our employees with respect and gratitude.
Located in beautiful Williams, Oregon, Herb Pharm is the nation’s leading liquid herbal supplement company. Comprised of a diverse organic farm and production facility, we work with more than 250 plants and distribute over 200 liquid herbal extracts to grocery, natural food, and specialty stores nationwide and have been for over 40 years!
We are looking for dedicated professionals to grow with our Quality team at our Williams, OR location. Read on to find out more below:
Position: Regulatory Compliance Manager
Department: Quality
Hours: Monday- Friday 8am-4:30pm PST
Location 20260 Williams Hwy, Williams, Oregon, 97544
Summary: The Regulatory Compliance Manager will serve a vital role at Herb Pharm. This position will be responsible for label and claim related compliance, including but not limited to marketing claims, structure/function claims, educational materials, etc. in accordance with applicable regulations. Additional responsibilities include oversight of the vendor qualification and product complaint processes. This position will work closely with Marketing, Sales, Customer Service, and Botanical Affairs.
Essential Duties & Responsibilities include the following, other duties may be assigned:
- Provide interdepartmental coordination and support for the substantiation, review, and approval of marketing claims, structure function claims, educational materials, etc. to ensure compliance with regulatory requirements and internal standards.
- Conduct literature searches and gather relevant scientific information to support product claim substantiation.
- Maintain an organized and accessible database supporting scientific substantiation.
- Participate in the Risk Assessment Committee.
- Support development, review, and approval of supplements facts panels, ingredient declarations, required warnings, etc.
- Coordinate with Product Innovation, Product Steering, and Product Change Teams to ensure timely filing of notifications to the Food and Drug Administration as required for dietary supplement label claims.
- Oversee the Vendor Qualification process in collaboration with Regulatory Specialist.
- Oversee the Product Complaint Coordination process in collaboration with Regulatory Specialist.
- Proactively identify regulatory issues and areas that may require improvements.
Qualifications & Requirements:
- Demonstrated understanding of the herbal supplement industry regulatory framework.
- Experience following current Good Manufacturing Practices (cGMP) Regulations and relevant Code of Federal Regulations.
- Ability to apply knowledge and experience to increasingly complex and/or ambiguous regulatory issues.
- Capacity to assess risk and communicate options with cross-functional peers.
- Ability to set clear priorities, track project progress, and present solution-based resolutions to obstacles encountered.
- Maintain professional and technical knowledge by attending approved events.
- Regularly lead and/or assist others with projects as assigned on compliance and process improvement with the Quality Management Team.
- Maintain a safe work environment by following all safety rules, maintaining a positive safety attitude, and ensuring that department employees participate in all required safety training or meetings.
Education and Experience:
- Bachelor’s degree in Science, Chemistry, Biochemistry, Pharmacology, Biology or related field; or an equivalent combination of four to six years related experience and/or education.
- 5+ years Regulatory experience in a cGMP or regulated manufacturing industry preferred.
- Extensive knowledge of the Dietary Supplement Health & Education Act (DSHEA), Nutrition Labeling and Education Act (NLEA) Labeling Regulations, Code of Federal Regulations Title 21 Part 101, 117, and 117 and the Food Allergen Labeling and Consumer Protection Act (FALCPA) Regulations.
- Advanced ability to interpret and apply applicable FDA regulations and guidance, as well as identify enforcement trends governing dietary supplements.
- Technical writing experience in a compliance environment or a scientific environment such as microbiology, food science, chemistry, or biochemistry is preferred.
Technical Requirements:
- Excellent math and working knowledge of data analysis/statistical methods.
- Advance Microsoft Suite capabilities highly preferred.
Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from people at all levels of the organization and external contracts. Strong attention to detail, solid knowledge of grammar and punctuation, ability to proofread accurately and consistently.
Reasoning Skills: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Interpersonal Skills: Ability to quickly organize and communicate thoughts, and to understand communications from others. Ability to maintain composure, professionalism, listen and respond appropriately.
Our generous benefits package includes a complete range of quality health benefits:
- Comprehensive group medical, dental and vision coverage for employees and dependents
- Coverage includes a variety of alternative health care options
- Prescription drug coverage with a mail order program
- Generous employee purchase discounts on our herbal products
- Employee assistance program
- Green Commuter Initiative to encourage carpooling, walking and biking to work
- Life, accident and disability insurance
- Paid vacation and personal time off
- Short term disability plan
- 401(k) retirement plan with generous company matching and profit-sharing features
Offer of employment is contingent upon a successful pre-employment screening and background check.
Herb Pharm, LLC is an equal opportunity employer and encourages applicants of diverse backgrounds to apply.