Regulatory Compliance Specialist

2 weeks ago


Bangor, Maine, United States Biospectra, Inc. Full time

Career Opportunity: Regulatory Affairs Specialist

BioSpectra, Inc. is seeking a dedicated Regulatory Affairs Specialist to enhance our operations in the pharmaceutical sector. As a pivotal member of our team, you will facilitate the connection between our products and regulatory bodies, ensuring compliance and excellence in all submissions.

Key Responsibilities:

  • Maintain a comprehensive understanding of applicable federal, state, and local regulations that impact BioSpectra and its products.
  • Specialize in the assembly of Modules 1, 2, and 3 for eCTD submissions related to Drug Substances and Excipients.
  • Ensure that all master files, including drug master files and active substance master files, are up-to-date and compliant with regulatory standards.
  • Timely inclusion of all BioSpectra Change Controls in regulatory submissions.
  • Organize and archive regulatory documents as necessary.
  • Analyze data to draw conclusions that support regulatory filings.
  • Stay informed about new regulations and changes, providing relevant updates to the regulatory team.
  • Offer regulatory guidance and summarize impacts on the quality system for relevant departments.
  • Prepare necessary documentation for drug substance listings for submission to global regulatory agencies.
  • Adhere to Good Documentation Practices in all regulatory submissions.
  • Assist in the preparation of regulatory documents as directed by management.
  • Support regulatory inspections, including responses and corrective action plans.
  • Ensure compliance with regulatory requirements outlined in Customer Quality Agreements.
  • Complete necessary regulatory documentation to facilitate product commercialization.
  • Contribute to the development and refinement of Regulatory Program procedures and policies.

Qualifications:

  • Bachelor's degree in a Science-related field.
  • A minimum of 4 years of experience in a cGMP environment, preferably related to Active Pharmaceutical Ingredients.
  • Familiarity with ICH Q7, 21 CFR 210 and 211, Part 11, and Annex 11.
  • Knowledge of Global Regulatory Affairs, including regulations in the United States, Europe, Canada, and Asia.
  • Strong analytical skills to define problems, gather data, and draw valid conclusions.
  • Proficiency in relevant software applications, including MS Office, Excel, Minitab, and Adobe.
  • Effective communication skills for interaction with staff, management, and regulatory agencies.
  • Ability to handle sensitive information confidentially.
  • Visual acuity for detailed work and the ability to use a computer for extended periods.

Work Schedule:

  • Exempt position requiring a minimum of 40-45 hours per week or an agreed-upon schedule.
  • Willingness to work from various BioSpectra facilities as needed.

Make a significant impact in the biopharma industry with BioSpectra, Inc.



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