Regulatory Affairs
Our expert regulatory affairs recruiters are standing by to discuss your hiring needs
One of the most dynamically changing environments is regulatory. Regulatory authority requirements are constantly evolving, submission timeframes are shrinking, and compliance demands are increasing. Regulatory is one of the hardest to fill positions in this candidate driven marketplace. Our regulatory recruiters leverage our 30 years of connections to get the specific regulatory affairs talent you need with expertise that includes:
Vice President Regulatory
Vice President Clinical and Regulatory Affairs
Director International Regulatory Affairs
Director Regulatory Affairs Strategy
Quality and Regulatory Director
Associate Director Regulatory Affairs
Regulatory Affairs Manager
Regulatory Operations Shared Services Manager
Regulatory Affairs Specialist
Vice President Regulatory Affairs and Quality
Senior Director of Regulatory Affairs
Director Regulatory Affairs
Director Regulatory Recon
Promotional Regulatory Affairs Director
Associate Director CMC Regulatory Affairs
Regulatory Compliance Manager
Senior Regulatory Affairs Specialist
Regulatory Affairs Associate
EXPERTISE
AREAS
GLOBAL AND US REGULATORY STRATEGY | REGULATORY STRATEGY AND SUBMISSIONS FOR BIOLOGICS, DRUGS, DEVICES, DIAGNOSTICS, COMBINATION PRODUCTS | NEW DRUG APPLICATIONS (NDAS) 505(B)(1) & 505(B)(2), GENERIC DRUG APPLICATIONS (ANDAS), DRUG MASTER FILES (DMFS), EUROPEAN PHARMACOPOEIA AND CERTIFICATES OF SUITABILITY (CEPS), MARKETING AUTHORIZATION APPLICATION (MAA) CLINICAL REVIEWS, 510(K)S, BLAS, CTAS, HDES, IDES, INDS, SAMDS | BIOLOGICS LICENSE APPLICATION (BLA) MEETINGS, TYPE 8 MEETINGS, PRE-INVESTIGATIONAL NEW DRUG (PRE-IND), END OF PHASE 2, PRE-NEW DRUG APPLICATION (PRE-NDA), ADVISORY COMMITTEE, ORPHAN DESIGNATION (FORMAL DESIGNATION REQUEST) | REGULATORY CMC | REMEDIATION ANALYSIS AND SUPPORT | ADVERTISING AND PROMOTIONAL REVIEW | LABELING FOR U.S. SUBMISSIONS, STRUCTURED PRODUCT LABELING (SPL) REQUIREMENTS AND ANALYSIS OF INNOVATOR LABELING, SIDE-BY-SIDE COMPARISON | FMEA, FMECA, HA, ISO 14971 ANALYSIS AND REMEDIATION
