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  • ID
    #46882946
  • Salary
    TBD
  • Source
    Kelly Services
  • Date
    2022-11-02
  • Deadline
    2022-12-31
 
Full-time

Vacancy expired!

Regulatory & Documentation SpecialistLocation: Oak Brook, ILJob Type: Direct hireShift: 1 st shift (Hybrid after 90 days – 2 days a week remote)Salary: $70KSummaryThe Regulatory & Documentation Specialist is responsible for performing duties associated with regulatory affairs and compliance requirements relevant to the OTC pharmaceutical industry.ResponsibilitiesAdministers and maintains the Company’s Change Control System for compliance documentation

Reviews and evaluates product labeling to ensure compliance with all regulations and requirements

Uses Food and Drug Administration (FDA) monographs and other regulations to develop compliant Drug Facts Box information including active ingredients and concentrations, uses, warnings, directions, and inactive ingredients

Uses guidance from international third parties to develop countryspecific formula ingredient lists.

Monitors regulatory activities (via searches of government internet web sites, review of USP supplements, Federal Register publications, and other government communication vehicles) and proactively presents, advises, and executes internal programs associated with these activities.

Maintains facility licenses and drug listings.

Administers the adherence to procedural requirements in the development of Master Records.

Reviews and approves specifications (labeling, raw materials, packaging, product certificates of analysis, etc.).

Prepares dossiers and supports the registration of Canadian and other international products.

Acts as the principal department contact for handling, planning, and responding to regulatory questions and requests.

Master the ability of reading, reviewing, and auditing documents and following procedures. Proficient at understanding the importance and the elements of a good change control process.

Proficiently understand the elements of a Product Master File and manage its lifecycle.

Working knowledge of US FDA OTC monographs and the cGMP compliance requirements for the Company's products.

Proficient at preparing and compiling product registration documents and dossiers.

Master the understanding of technical requirements for all quality and regulatory documentation supporting batch production documents and their lifecycle.

SME for the understanding of the cGMP requirements associated with the production and Quality life cycle of an OTC drug.

Ability to understand and interpret product regulatory requirements from FDA OTC monographs, US Pharmacopeia and/or others, local, state, federal and international regulatory agencies.

Master the ability to monitor regulatory activities (via searches of government internet web sites, review of USP supplements, Federal Register publications, and other government communication vehicles) and understand their impact to the Company.

Demonstrate the ability to proactively present, advise, and execute internal programs associated with these activities

RequirementsBachelor's degree in Chemistry, Biology, or related scientific discipline

3-5 years of applicable Quality Assurance environment experience, preferably in the cosmetics/pharmaceutical OTC industry or 1-2 years of applicable Regulatory Affairs experience in the cosmetics/pharmaceutical OTC industry.

Master's degree in Regulatory/Quality, or related scientific discipline

1-3 years of applicable Quality Assurance environment experience, preferably in the cosmetics/pharmaceutical OTC industry or 1-2 years of applicable Regulatory Affairs experience in the cosmetics/pharmaceutical OTC industry.

Attention to detail and ability to work well under pressure.

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.Why Kelly ® Science & Clinical?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly ®At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.

Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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