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

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