Overview:
statement:
the specialist, global regulatory affairs & product compliance works in a cross-functional environment to assist the 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.
additionally, this role will be responsible for the coordination of corporate projects including global product launches, reformulations, and new corporate initiatives.
detailed responsibilities:
- effectively interact and communicate with regional counterparts, manufacturers, and other departments (including project management, qa, and r&d/scientific affairs) regarding 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 (coa's), stability study reports, manufacturer statements, and scientific substantiation documents.
- work with project management and change management to ensure the creation of new skus, 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.
job qualifications:
supervisory responsibilities:
none
required qualifications:
*skills*:
- excellent oral and written communication skills in english
- detail-oriented with the ability to analyze complex technical data
- excellent organizational skills and ability to multitask
- 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
languages:
- intermediate in english
*experience*:
- at least 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:
- advanced in english