Talent.com
Regulatory Affairs Document Specialist

Regulatory Affairs Document Specialist

Apex SystemsPhoenix, AZ, US
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Regulatory Affairs Specialist

Well established and growing nutraceutical company is growing their team and adding to their Regulatory Affairs department!

General Description : Responsible for ensuring regulatory compliance of applied ingredients and products with focus on all international markets' requirements. The Regulatory Affairs Specialist is also responsible for formula and label reviews, product registration, claims substantiation, and supporting the work associated with obtaining governmental approval for product imports into international markets.

Essential Duties / Responsibilities / Functions :

  • Prepares and supports global product registration and product releases in accordance with applicable regulations.
  • Evaluates the regulatory environment and provides internal advice through the product lifecycle (i.e. concept, development, manufacturing, marketing) to ensure product compliance.
  • Identifies requirements and potential obstacles for market access and distribution.
  • Determines requirements (local, national, international) and options for regulatory submission.
  • Prepares documents, communicates, and maintains record keeping for product registration renewals for countries according to applicable regulatory requirements and guidelines.
  • Reviews and ensures compliance and technical accuracy of applicable documents to assemble registration dossiers.
  • Researches, studies, and interprets country specific regulations using a variety of sources including governmental authorities' websites, trade organizations, recognized world standards organizations, etc. and determine applicability.

Performs review and ensure regulatory compliance of ingredients, formulas, packaging components, labels, product claims, and specifications in the assigned markets, as well as adheres to company's policies and guidelines. Identifies and maintains procedures for the registration and exporting of products into assigned markets (domestic and foreign). Performs and manages country legalizations tasks including requesting money, contacting courier, placing request for embassy legalizations, mailing and tracking documents, etc.

Provides requirements and recommendations and interact with cross-functional teams across various business units, partners, contractors, and government entities to support project goals, effective product registration and launching in assigned markets. Works closely with Research and Development (R&D), Marketing, Supply Chain and Quality, providing regulatory compliance guidance for dietary supplements, foods and cosmetics.

  • Creates, revises, and maintains records of master labels as applicable per assigned region.
  • Partners globally with business teams to identify product export requirements and workflow opportunities to meet scheduled product registration dates.
  • Works closely with Operations and Logistics teams to gather information and obtain approvals for new and reformulated product launches.
  • Stays abreast of international regulatory developments and identifies opportunities and / or implications to the business.
  • Maintains accurate and up-to-date regulatory records and databases.
  • All other duties as assigned.

    • Qualifications & Skills Required to Perform Job Duties :

  • Must be proficient in Microsoft Office software, including Word, Excel, PowerPoint, and Outlook.
  • Must be able to manage projects and create project plans and timelines.
  • Must be able to organize and track complex information.
  • Must be able to communicate with diverse audiences and personnel.
  • Strong research and analytical skills.
  • Ability to write and edit technical documents.
  • Ability to effectively communicate and interact internally and externally with regulatory agencies and consultants.
  • Ability to communicate and network with scientific and regulatory personnel to obtain necessary information.
  • Strong verbal and written communication skills.
  • Attention to detail and strong proofreading skills.
  • Strong problem-solving skills. Uses experience and judgment to resolve complex issues and problems and refers to senior management when needed.
  • Possesses solid working knowledge of subject matter.

    • Physical Requirements to Perform Job Duties :

  • Must be able to sit in front of computer for extended periods.
  • Must be able to perform light lifting and be able to move between locations in the building.
  • Must be able to work in an environment that may contain residual dust and smells of the raw ingredients used in the manufacturing of products.

    • Education and / or Experience Required to Perform Job Duties :

    Bachelor's degree or equivalent work experience. A Bachelor of Science degree is preferred. 0-2 years of experience in regulatory affairs or related fields. EEO Employer

    Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.

    serp_jobs.job_alerts.create_a_job

    Document Specialist • Phoenix, AZ, US