Regulatory Affairs Specialist (Small Molecule IND, NDA, Module 3)

Regulatory Affairs Specialist (Small Molecule IND, NDA, Module 3)

Job Summary

This critical role demands extensive hands-on expertise in modifying regulatory strategies, authoring scientifically robust Chemistry, Manufacturing, and Controls (CMC) documentation within Module 3 of the eCTD, and managing submissions for Investigational New Drug (IND) and New Drug Applications (NDA) specifically for small molecule drugs.

Key Responsibilities

• Submission Authoring & Management: Lead the planning, authoring, compilation, review, and submission of global regulatory filings, including original Investigational New Drug (IND) applications, New Drug Applications (NDA), amendments, supplements, and annual reports for small molecule products.
• Module 3 Expertise (Small Molecule Focus): Serve as the subject matter expert for the Chemistry, Manufacturing, and Controls (CMC) section (Module 3) of regulatory dossiers. Ensure all documentation for small molecule active pharmaceutical ingredients (APIs) and drug products is scientifically accurate, compliant with eCTD requirements, FDA regulations, and ICH guidelines, covering aspects like synthesis, characterization, stability, and process validation.
• Documentation & Compliance: Review and approve product labeling and technical documentation specific to small molecule characteristics for regulatory compliance. Maintain accurate records of all regulatory submissions and correspondence in designated systems.
• Post-Approval Activities: Oversee and provide strategic direction for lifecycle management submissions, including post-approval changes and variations specific to API source changes, manufacturing site transfers, and formulation updates for small molecule products.
• Regulatory Intelligence: Monitor and interpret changes in domestic and international regulations and guidelines pertaining specifically to small molecule drug development, ensuring the organization remains current with evolving requirements.

Qualifications and Experience

• Education: A bachelor's degree in a life science, chemistry, pharmacy, or related scientific field is required.
• Experience: A minimum of 5-8 years of experience in regulatory affairs within the pharmaceutical industry, with a proven track record of authoring and managing IND and NDA submissions with preference for knowledge of small molecule drugs.
• Technical Skills:
  • Deep expertise in FDA and ICH guidelines for small molecule drug development and submissions.
  • Extensive hands-on experience authoring Module 3 (Quality/CMC) of the eCTD for small molecules.
  • Strong knowledge of cGMP, Google Cloud Platform, and GLP regulations.