Looking to join a stable organization that is a leader in product innovation in the personal care industry? Are your seeking opportunities to grow professionally and personally within the OTC environment? Blistex is seeking a dedicated, detail oriented individual to join our growing regulatory affairs team.
The Regulatory & Documentation Specialist is responsible for performing duties associated with regulatory affairs and compliance requirements relevant to the OTC pharmaceutical industry and Blistex Inc.
ESSENTIAL JOB FUNCTIONS
- Administers 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 country-specific 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
REQUIRED EDUCATION, EXPERIENCE AND SKILLS
- Bachelor's degree in Chemistry, Biology, or related scientific discipline with 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.
- Attention to detail and ability to work well under pressure.
- Master's degree in Regulatory/Quality, or related scientific discipline with 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.
Employment/Position Type:Full Time
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