Seasoned Regulatory CMC Expert
25+ years of experience in the pharmaceutical industry in areas of regulatory affairs (CMC) and analytical method development /validation. Expertise in cGMP regulations, compliant processes and well versed in FDA regulations and ICH Guidelines. Strong organization skills, prioritization and ability to manage diverse project loads. Handling out of specification (OOS), failure investigations, and corrective and preventive actions (CAPA). Collaborated in audits from various US and European agencies and conducted GMP compliance audits of vendors.
- Combination Products
- Drug Delivery
- Small Molecules
Relevant Therapeutic Areas
- Allergy & Immunology
- Executive Director, CMC
- Senior Director, Quality & Analytical Sciences
- Associate Director, Analytical Development
- Greater New York Area
- Open to remote and in-office
- Small Biotechs
Skills & Accomplishments
- Extensive experience in the pharmaceutical industry in areas of regulatory affairs (CMC- Module 3 and 2 Quality), Quality System, and Analytical method development/validation.
- Proven technical leader with expertise in cGMP regulations, Lab compliance, Data integrity, FDA regulations, and ICH guidelines.
- Authored IND, DSUR, CTD (Health Canada) post-approval submission (CBE-30, PAS, and CBE-0) and responded to over 50 complete response letters for ANDA and Information Request for NDA.