Regulatory Compliance Specialist

2 weeks ago

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

Career Opportunity: Regulatory Affairs Specialist

At BioSpectra, we are dedicated to supporting leading pharmaceutical companies worldwide. We are seeking a knowledgeable Regulatory Affairs Specialist to enhance our operations.

Role Overview: As a Regulatory Affairs Specialist, you will be instrumental in liaising between organizations, their products, and regulatory bodies. The successful candidate will possess strong communication, analytical, and project management capabilities to navigate complex information, interact with various stakeholders, and manage multiple deadlines efficiently. A keen eye for detail, problem-solving aptitude, and a commitment to ethical practices are essential for upholding BioSpectra's high-quality standards.

About BioSpectra, Inc.: We are a privately owned, family-oriented business and a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including APIs, excipients, GMP process chemicals, and bulk GMP buffers and solutions.

Why Consider BioSpectra, Inc.?

  • Support leading pharmaceutical clients globally.
  • Advance your career within a growing organization offering numerous professional and personal development opportunities.
  • Comprehensive benefits package including medical, dental, vision, and tuition reimbursement.
  • 401K Retirement Savings Plan with company matching contributions.
  • Generous paid time off programs, including vacation, sick leave, personal time, and paid holidays.

Key Responsibilities:

  • Maintain an understanding of applicable federal, state, local, and company regulations relevant to BioSpectra and its products.
  • Specialize in compiling Modules 1, 2, and 3 of eCTD filings for Drug Substances and Excipients.
  • Ensure compliance of all drug master files, veterinary master files, active substance master files, and CEPs with regulatory agency requirements.
  • Timely inclusion of all BioSpectra Change Controls in Regulatory Submissions.
  • File and archive regulatory documents as necessary.
  • Analyze data and draw conclusions to support regulatory filings.
  • Stay updated on new regulations and changes, providing relevant information to the regulatory team.
  • Offer regulatory guidance and summarize impacts on the quality system to relevant departments.
  • Prepare support documents for drug substance listings for submission to regulatory agencies as directed by management.
  • Ensure adherence to Good Documentation Practices for all regulatory submissions.
  • Prepare all regulatory documents as assigned by management.
  • Assist during regulatory inspections, including necessary responses and CAPA plans.
  • Maintain compliance with Regulatory Requirements in Customer Quality Agreements.
  • Complete regulatory and compliance documentation requests to facilitate product commercialization.
  • Contribute to the development and refinement of Regulatory Program procedures and policies.

Qualifications:

  • Bachelor's degree in Science or a related field.
  • A minimum of 4 years of experience in a cGMP environment, preferably related to Active Pharmaceutical Ingredients.
  • Working knowledge of ICH Q7, 21 CFR 210 and 211, Part 11, and Annex 11.
  • Familiarity with Global Regulatory Affairs, including regulations in the United States, Europe, Canada, and Asia.
  • Ability to identify problems, gather data, establish facts, and draw valid conclusions.
  • Proficiency in relevant software applications, including MS Office, Excel, Minitab, and Adobe.
  • Effective communication skills with staff, management, customers, and regulatory agencies.
  • Ability to handle sensitive information confidentially.
  • Visual acuity for close and distance vision, ability to adjust focus, and capability to use a computer for extended periods.

Work Schedule:

  • Exempt position.
  • Minimum of 40-45 hours per week or an agreed-upon documented schedule.
  • Willingness to work from various BioSpectra facilities.

Make a meaningful impact in the biopharma sector.

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