Regulatory Affairs Associate

at  Captek Softgel International

Become part of a team that champions wellness worldwide. CAPTEK® Softgel International is a global leader in the development and production of high-quality nutraceutical supplements. As a contract manufacturer organization (CMO), we collaborate with innovators from some of the world’s most successful brands.

EDUCATIONAL QUALIFICATION:

• Bachelor’s or advanced degree in scientific discipline.

REQUIRED SKILLS / EXPERIENCE:

• Strong project management and organizational skills with emphasis on attention to detail.
• Excellent interpersonal and verbal/written communication skills with the ability to build relationships at all levels of the organization.
• Ability to work independently on multiple projects with tight timelines and minimal supervision.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Gather documents and fill out forms for any new bids we receive as well as update forms and documents for already existing customers.
• Filling out any other forms online that customer needs; for example, the Palm Oil Survey, Allergen Questionnaire.
• Update WERCS, a portal for products’ information.
• Request and gather documents from vendors for our library as well as requests from customers.
• Requesting documents for Regulatory Affairs department needs for customer project.
• Ongoing RMR project that involves intensive updating of the log we are recreating as well as requesting the documents to make sure that the log is up to date especially with the changes in the Dietary Supplement world.
• Keeping the folders for both Vista and Cerritos updated and organized.
• Creating label review templates, reviewing the basic information on label, and gathering any necessary documents for said label review.
• Organizing and keeping track of the labels that are updated or revised
• Track review tasks of labels on Blue Arc, and other online portals.
• Ensuring that the labels and packaging information match individual products.
• Working to finalize Finish Product Specs by making sure to provide correct and the most up to date label that can be utilized to finish any FPS.
• Getting documents for Regulatory Affairs use in Syspro.
• Responding to Customer Service Requests, for labels, raw material document or forms requests.
• Organizing and updating the folders for Customers.