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.

Job Description

As a Regulatory Affairs Associate, you will be in role supporting our teams by managing and updating essential documents and forms for customer bids. You will support Regulatory Affairs by organizing documents for customer projects, maintaining RMR project logs, and ensuring regulatory compliance. Additional duties involve organizing folders for multiple job sites, creating and reviewing label templates, tracking label review tasks, finalizing Finish Product Specs (FPS), responding to customer service requests, and maintaining updated customer folders. Strong organizational skills and attention to detail are essential for success in this role.

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 Customer profiles into database(s)

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.

Work Environment:

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles and risk of electrical shock.
• The noise level in the work environment is usually moderate.

Physical Demands:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include Close vision, Peripheral vision and Ability to adjust focus. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear.

EEOC Statement:

CAPTEK is an equal employment opportunity employer. In order to provide equal opportunities to all individuals, employment decisions will be based on merit, qualifications, and abilities, not on any mental or physical disability. We comply with the law regarding reasonable accommodation for disabled employees and applicants.

We do not discriminate on the basis of actual or perceived race, color, national origin, ancestry, sex (which includes pregnancy, childbirth, breastfeeding and medical conditions related to pregnancy, childbirth or breastfeeding), reproductive health decisions, gender, gender identity, gender expression, religious creed, disability (mental and physical) including HIV and AIDS, medical condition (cancer and genetic characteristics ), genetic information, age, marital status, sexual orientation, military and veteran status, or any other characteristic protected by federal, state or local law. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.