in accordance with regulatory strategy. They will work cross-functionally with R&D, quality, clinical operations, medical affairs... launched products. Primary Duties & Responsibilities Leadership and Management: Lead and manage the regulatory affairs...
+ years' experience working in Pharma/Biotech Regulatory Affairs and within different areas (CMC, Labelling, Clinical... US submissions with in-depth knowledge of regulatory requirements for US Understanding of CMC, Labelling, Clinical within pre...
documents for electronic submissions. Coordinate with cross-functional teams, including Regulatory Affairs, Clinical... knowledge of nonclinical, clinical, CMC, DMF, and labeling/SPL submission documents. Familiar with regulatory guidelines...