Regulatory Compliance Specialist
2 weeks ago
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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