The International Regulatory Specialist is responsible for collecting, organizing and creating documents required for international regulatory filings and registrations. Then International Regulatory Specialist will work with internal teams, contract manufacturers and 3rd party brands to assemble the required documents, ensure their compliance with international regulations, and then manage the ongoing database of product documentation.
Responsibilities Request, collect, and maintain documents pertaining to existing and new product registrations which may require interactions with external vendors. Prepare international dossiers for new product submissions to local Ministries of Health in accordance with country regulations. Legalize regulatory documents as needed. Responsible for applying for FDA required documents. Track regulatory submissions to ensure there are no preventions were given and if there are preventions, be able to support with additional documentation if required for approval.Manage a structured database for all documentation related to regulatory documents and international assortments. Keep abreast of product transfers, label revisions, product statuses and update country assortments as necessary.May provide strategic assortment selection by category to register new SKUs. Attend and lead regulatory meetings.Create timelines and monitor to generate reports on regulatory progression.Other Functions:
Other project and duties as assigned. QualificationsEducation/Certification:
Associate degree or BA/BS degree in administration, life sciences, International relations or documentation preferred.Required Knowledge:
Supplement industry product development and formulation.Familiarity with Dietary and Food Supplements and their applications for healthy lifestyles.Experience required:
2– 5 years of product development experience.A minimum of 2 experience in domestic/international regulatory submissions and/or regulatory compliancePreferred knowledge in working with GMPs, COAs, and FDA Certificate of Free SalePreferred working with Foreign Ministries of Health for Registration of Health and/or Dietary and Food Supplement products.Experience working with Local, State, Federal US Agencies, and Embassies for legalization and registration requirements of documentsSkill and Ability:
Excellent written and oral communication skills. Proficient in MS office software.Ability to work on multiple concurrent tasks/activities and meet corporate strategies. Ability to read, analyze, and interpret documents.Ability to effectively present information in written and oral form and respond to questions from international customers and regulatory agenciesAbility to build relationships across functional boundaries at multiple levels. Strong technical, analytical and problem solving skills, including strong project management skills.Detail oriented with excellent time management skillsMust have a great attitude and a can do philosophy
Equal Opportunity Policy
The Vitamin Shoppe is an equal opportunity employer. We respect diversity and accordingly are an equal opportunity employer that does not discriminate on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex, gender, gender identity or expression (including transgender status), sexual orientation, marital status, veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws. Our management is dedicated to ensuring the fulfillment of this policy with respect to hiring, placement, promotion, transfer, demotion, layoff, separation, recruitment, pay and other forms of compensation, access to facilities and programs, training and general treatment during employment.
We firmly believe that every Health Enthusiast has the right to be treated with dignity and respect. Our goal is to maintain a satisfied and productive team of Health Enthusiasts. The keys to reaching that goal are effective leadership, equal application of fair human resources policies, competitive wages and benefits, and close attention to all health enthusiast matters. The Vitamin Shoppe is committed to the principle of fair and impartial treatment of our Health Enthusiasts.
Health Enthusiasts with questions or concerns about equal employment opportunities in the workplace are encouraged to bring these issues to the attention of their Human Resources representative. We will not allow any form of retaliation against Health Enthusiasts who raise issues of perceived discrimination in good faith. To ensure our workplace is free of artificial barriers, violation of this policy may result in disciplinary action, up to and including discharge.
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