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The Vitamin Shoppe Specialist, International Regulatory in Secaucus, New Jersey

Overview

The International Regulatory Specialist is responsible for collecting, organizing and creating documents required for international regulatory filings and registrations. The IRC will work with internal teams, contract manufacturers and 3 rd party brands to assemble the required documents, ensure their compliance with international regulations, and then manage the ongoing database of product documentation.

Responsibilities

  • Collect, produce, maintain, and distribute documents pertaining to new and ongoing product registration worldwide.

  • Prepare international submissions for new products and product changes as required to ensure timely approval for market release and in accordance with applicable regulations, standards and guidance.

  • Advise technical, marketing and sales personnel on regulatory requirements.

  • Maintain regulatory affairs product files to support compliance with requirements and standards.

  • May generate technical files and declarations of conformance.

  • Assist in the managing of a structure function database for all documentation related to regulatory document and images.

  • Develop product monographs/literature, dossiers, and other type of registration documents

Other Functions:

  • Other project and duties as assigned.

Qualifications

Education/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 compliance

  • Preferred 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 documents

Skill 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 agencies

  • Ability to build relationships across functional boundaries at multiple levels.

  • Strong technical, analytical and problem solving skills, including strong project management skills.

  • Ability to make quick adjustments to established schedules to solve unexpected problems.

  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

ID 2021-25315

Category Accounting/Finance

Location US-NJ-Secaucus

We support diversity with a respectful, inclusive culture as an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran, or disabled status, or genetic information.

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