Vice President, Regulatory Science

BA/BS degree required; Master’s/PhD/PharmD in life sciences preferred At least 15 years of experience in pharma/biotech industry in Regulatory Science Experience in building teams and managing people Strong strategic and analytical abilities Working knowledge of the Code of Federal Regulations and FDA, EMA and ICH guidelines Expert knowledge of FDA and ICH GxP regulations and guidelines FDA Investigational New Drug Applications (IND), New Drug Applications (NDA), Biologics Liscence Application (BLA) and Drug Master Files (DMF) submission experience NDA / CTD dossier preparation, management and submission experience Product label development and management experience Knowledge and understanding of product life-cycle post-approval management Excellent interpersonal, communication, analytical, and organizational skills

Develop, implement, and maintain global regulatory strategies Build and maintain strong leadership capabilities within the regulatory team Oversee U.S. / international submissions and strategic interactions with Health Authorities Oversee submission and maintenance of global regulatory filings Assure compliance with relevant regulations and guidelines Communicate with and manage consultants, CROs, and other vendors Develop regulatory strategies and submission plans Oversee regulatory activities, including preparation and submission of regulatory documents Oversee CMC Regulatory Submissions Act as primary point of contact for external collaborations