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Regulatory Affairs Specialist

2 months ago

New York, New York, United States GForce Life Sciences Full time
Job Summary

GForce Life Sciences is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance and expertise on CMC regulatory matters to ensure compliance with global regulatory requirements and guidance.

Key Responsibilities
  • CMC Regulatory Strategy: Develop and implement CMC regulatory strategies for investigational, new, and marketed biologic and small molecule drug products to ensure compliance with global regulatory requirements and guidance.
  • Regulatory Document Preparation: Prepare, coordinate, and review all CMC and GMP-related documents for submission to regulatory authorities to ensure compliance with regulatory, company standards, and scientific/technical requirements.
  • Regulatory Compliance: Ensure that all CMC and GMP-related activities are conducted in compliance with regulatory requirements and company standards.
  • Collaboration and Communication: Collaborate with cross-functional teams, including manufacturing and quality groups, to ensure effective communication and coordination of CMC regulatory activities.
  • Regulatory Knowledge and Expertise: Stay up-to-date with global regulatory requirements and guidance, and provide expert advice and guidance to the team on CMC regulatory matters.
Requirements
  • Experience: 7 years or more of CMC regulatory experience in the pharmaceutical industry with a history of successful investigational filings and approvals of marketing applications as the CMC Regulatory lead.
  • Education: Bachelor's degree in Pharmaceutical Sciences or Chemistry or Pharm.D., Master's and Ph.D. preferably majoring in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology.
  • Skills: Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP, and related issues; knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval; and proficiency in regulatory software and systems.
Preferred Qualifications
  • RAC Certification: Regulatory Affairs Certification (RAC) is highly desirable.
  • Regulatory Experience: Experience in handling controlled substance applications and regulatory experience in the pharmaceutical industry.