Job Title: Regulatory and Documentation Specialist
Pay: $65,000 - $75,000
The Regulatory and Documentation Specialist is responsible for handling, planning, and responding to regulatory questions and requests. She/he is responsible for compliance documentation inclusive of FDA requirements as they relate to drug facts (labeling and monographs), active ingredients, concentrations and warnings. The position also uses guidance from international third parties to develop country-specific formula ingredient lists as required.
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.
- 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.
- Interfaces with Canadian and other international third parties to ensure regulatory compliance.
- Interfaces with R&D staff and provides support in the compilation and submission of records for new product launches.
- Participates in facility audits and on issue-specific committees, as required by the Supervisor, Regulatory Affairs.
Education, Experience, and Skills:
- Develops and implements creative regulatory strategies, approval schedules, and submission standards to achieve department and organization objectives.
- Performs and assumes other duties and responsibilities, as may be required by the Supervisor, Regulatory Affairs.
- Supports the Winner’s Circle and Quality System processes.
Physical Demands and Environment:
- A 4-year technical college degree in a specialized field such as science or technology; or equivalent in knowledge and training.
- The knowledge and skills required for this position are typically acquired in 4 to 5 years of experience in a pharmaceutical and/or OTC regulatory environment.
- Attention to detail and ability to work well under pressure.
- Effective interpersonal skills to interact with various levels of internal and external customers.
- Good oral and written communication skills in business English (spelling, grammar, and punctuation).
- Computer literacy in a Windows environment (Word, Excel, and Outlook).
- Ability to prepare detailed and accurate documentation.
- Familiarity with International Cosmetics and Sunscreens regulations as they relate to FDA OTC regulated drug products.
- Working knowledge of Current Good Manufacturing Practices (cGMP).
- Strong organizational and analytical abilities.
- Ability to work independently and meet deadlines on a multitude of concurrent tasks.
- Willingness to accept other duties, as assigned.
- Discretion with confidential information.
- Ability to develop and maintain an effective working relationship with internal and external customers, function as a team player, accept constructive criticism from management, and comply with Company policies.
- This position requires the individual to Stand or Walk up to 33% of the time. This position requires the individual to Sit, Talk or Hear, and use hands to Finger, Handle or Feel 66 to 100% of the time. This position requires the individual to reach with hands and arms 33 to 66% of the time.
- This position will require the individual to lift up to 10 pounds 33 to 66% of the time.
- The vision requirements for this position includes close vision of 20 inches or less; distance vision of 20 feet or more, color vision (ability to distinguish between colors), peripheral vision (ability to see up, down, left, right while eyes are fixed on a given point), depth perception (3 dimensional vision), and ability to adjust focus (ability to adjust the eye to bring an object into sharp focus).
- This position has no exposure to measurable environmental hazards or conditions.
- The noise level for this position will Be Moderate Noise (Ex: Business office with typewriters and/or computer printers, light traffic).