Job Description
Overview:
POSITION SUMMARY STATEMENT:
The Global Regulatory Affairs & Product Compliance Specialist works in a cross-functional environment to assist the North America (NAM) regional teams in obtaining and maintaining registrations and/or authorizations necessary for commercialization of food, food supplements, dietetic products, energy drinks and personal care products in the regions of responsibility. Additionally, this role will be responsible for the coordination of corporate projects including global product launches, reformulations and new corporate initiatives.
DETAILED RESPONSIBILITIES/DUTIES:
- Effectively interact and communicate with regional counterparts, manufacturers, and other departments (including Project Management, QA, and R&D/Scientific Affairs) with regard to all aspects of product compliance and the product lifecycle.
- Conduct review of preliminary and concept formulas and supporting documentation to determine overall acceptability and appropriate product classification, for use in corporate initiatives and product launches, including the assessment of ingredients, nutritional claims and other formula specifications (i.e. heavy metals, allergens).
- Perform vitamin and mineral conversions, calculation of formula theoretical inputs, nutritional claims, percent daily values (%DV), and specification ranges.
- Develop, request, and review supporting technical and non-technical data and documentation from manufacturers, technical libraries and various departmental sources. These include Certificates of Analysis (COAs), Stability Study Reports, manufacturer statements, and scientific substantiation documents.
- Work with Project Management and Change Management to ensure the creation of new SKU's, and drive changes to raw materials, formulas, and printed components; ensuring receipt of necessary licenses prior to the completion of product release.
- Develop country specific labels by extracting information from formula and specification sheets; assess label acceptability and identify discrepancies based on country labeling regulations.
- Attend cross functional meetings and serve as department lead, providing notes, reports, and follow-up to regional counterparts and managers.
- Gather data and input from Regional Regulatory Affairs teams and analyze the information gathered to prepare reports and summaries.
- Gather and analyze country specific regulations and guidance for projects of responsibility and keep abreast of any changes or developments.
- Perform additional duties as assigned.
- May be required to travel internationally less than 5% of the time.
SUPERVISORY RESPONSIBILITIES:
None
Qualifications:
REQUIRED QUALIFICATIONS:
Skills:
- Excellent oral and written communication skills in English
- Highly attentive to detail
- Ability to analyze complex technical data
- Excellent organizational skills and ability to multitask
- PC skills (email, word-processing, spreadsheets, etc.)
- Team player with good people skills
- Ability to adapt in a fast-paced setting with evolving goals and objectives
- Ability to think critically, analyze problems and provide creative solutions
Experience:
- 1 year of relevant work (in addition to corresponding coursework projects) or internship experience in food, nutrition, pharmaceutical or related fields
Education:
- Bachelor's degree in nutrition, biology, chemistry, food science, pharmacy, legal or related field
PREFERRED QUALIFICATIONS:
- Bilingual
- 3 years industry or related work experience in a regulatory or compliance environment
- Masters degree or Certification in regulatory affairs, nutrition, biology, chemistry, food science, pharmacy, legal, business, or related field
US Benefits Statement:
Herbalife offers a variety of benefits to eligible employees in the U.S. (limited to the 50 States and the District of Columbia), which includes Group Health Programs, other Voluntary Benefit Programs, and Paid Time Off. Group Health Programs include Medical, Dental, Vision, Health Savings Account (HSA), Flexible Spending Accounts (FSA), Basic Life/AD&D; Short-Term and Long-Term Disability, and an Employee Assistance Program (EAP). Other Voluntary Benefit Programs include a 401(k) plan, Wellness Incentive Program, Employee Stock Purchase Plan (ESPP), Supplemental Life/Critical Illness/Hospitalization/Accident Insurance, and Pet Insurance. Paid time off includes Company-observed U.S. Holidays, Floating Holidays, Vacation, Sick Time, a Volunteer Program, Paid Maternity and Paternity Leave, Bereavement Leave, Personal Leave and time off for voting.
Job Tags
Holiday work, Temporary work, Work experience placement, Internship, Flexible hours,