Vice President of Regulatory Affairs

Paramount BioCapital dedicates its own capital to seed companies through formation, the in-licensing of drug candidates and the initial stages of product development. Through its NASD-registered broker-dealer affiliate, Paramount raises additional funds from institutional and high net-worth investors, typically taking its affiliated companies public and gaining them exposure to the investment community. Paramount’s experience in developing life sciences companies allows management to remain focused on the development of drug candidates rather than building infrastructure. Paramount believes that its model helps limit developmental delays occasioned by management distraction and facilitates management effectiveness.

 

Since its inception, Paramount and its affiliated companies have been involved in the clinical development of more than fifty drug candidates – several of which have reached the market- and have over thirty compounds in clinical development today. Paramount has extensive experience in all facets of the development of emerging life sciences companies and provides its portfolio companies with a wide range of professional and financial support services.

 

For immediate consideration please send your resume as an attachment to: careers@paramountbio.com

 

Requirements

•  Thrive in an entrepreneurial environment
• Advanced degree preferred but not required in the field of medicine, toxicology, pathology, pharmacology, regulatory affairs, or other relevant scientific discipline
• At least 10 years of industry experience in regulatory affairs, preferably in a biotechnology setting
• Broad understanding of product development for biologics and small molecule therapeutics
• Familiar with regulatory requirements for product development and marketing approval in the US, EU, and ROW, including common challenges associated with CMC, nonclinical studies, and clinical trials
• Comfortable working on cross-functional teams
• Broad experience preparing INDs, BLAs, NDAs, and other regulatory documents
• Familiar with US and EU GXP standards
• Track record of successfully managing consultants, vendors, and other collaborators
• In touch with current practices and trends in the pharmaceutical industry
• Excellent communication, organization, interpersonal and writing skills
• Ability to collaborate and influence effectively

Responsibilities:
•   Provide leadership and guidance to colleagues on issues related to regulatory affairs and drug development
•   Work with cross-functional teams to create product development plans that identify regulatory risks and mitigation strategies
•   Manage vendors and consultants involved in regulatory document preparation and submission
•   Represent Paramount and associates at regulatory agency meetings
•   Work with colleagues to complete scientific due diligence on in-licensing opportunities
•   Serve as project team leader for selected development programs