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Regulatory Affairs Specialist
2 months ago
We are seeking an experienced Regulatory Affairs Specialist to join our team at BioSpectra, a leading manufacturer of GMP pharmaceutical-grade ingredients. As a key member of our regulatory team, you will play a crucial role in ensuring compliance with global regulatory requirements and supporting the success of our top 25 pharmaceutical company customers.
Key Responsibilities:- Maintain an understanding of current federal, state, local, and company regulations applicable to BioSpectra and its products.
- Specialize in the compilation of Modules 1, 2, and 3 of the eCTD filings for Drug Substances and Excipients.
- Ensure all drug master files, veterinary master files, active substance master files, and CEPs are current and compliant with regulatory agency requirements.
- File and archive regulatory documents as required.
- Review data and establish conclusions based on the evaluation of data to support regulatory filings.
- Remain current with new regulations and regulatory changes and provide the regulatory team with applicable information.
- Provide regulatory information, guides, and summaries of the impact to the quality system to applicable departments, as appropriate.
- Four-year degree in Science or related field.
- Four-year minimum experience working in a cGMP environment, ideally Active Pharmaceutical Ingredient related.
- Working knowledge and understanding of ICH Q7, 21 CFR 210 and 211, Part 11, and Annex 11.
- Knowledge of Global Regulatory Affairs, including but not limited to United States, European, Canada, and Asia.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Experience with relevant software applications, including MS Office, Excel, Minitab, and Adobe.
- Ability to communicate effectively with staff, management, customers, and/or regulatory agencies.
- Ability to handle sensitive information in a confidential manner.
- Comprehensive Benefits Package, including Medical, Dental, Vision, Company-paid Life Insurance, and Tuition Reimbursement.
- 401K Retirement Savings Plan with Company match.
- Excellent Paid Time Off Programs, including vacation, sick, and personal time, plus paid holidays.
Ready to make a difference in the biopharma industry? Apply now and be part of a talented team driving excellence at BioSpectra.
