Vice President of Regulatory Affairs

COMPANY

Our client is developing novel pharmaceuticals for a variety of inflammatory and infectious diseases leveraging a proprietary, small molecule chemical library. The company has compounds with antibiotic, anti-viral, anti-fungal, and anti-inflammatory properties. Initially the company has focused on developing drugs for dermatological disorders.
JOB DESCRIPTION

Oversee submissions to domestic and international regulatory bodiesDevelop and execute Regulatory Affairs and Quality Assurance strategic and annual plansWork collaboratively across a broad range of people, functions and disciplines to achieve strategic goalsOversee and implement strategies for earliest possible approvals of phase 1 through phase 4 applicationsLead and have final responsibility for compilation of all relevant regulatory filings (IND, NDA and alike)Oversee the evaluation and analysis of the impact of trends relative to government regulatory activitiesLead and manage Regulatory Affairs, allocating and directing internal resources and effectively utilize outsourcing to achieve project and business goals in a timely mannerBuild the regulatory affairs department and provide strategic direction for the evolution of this function in a growing pharmaceutical development organizationCoordinate and lead creative and constructive interactions with regulatory agencies to ensure that all R&D projects have clearly defined regulatory paths and milestones leading to successful filings and approvalsDirect initiatives that accomplish continuous improvement and cost effectiveness and enhance efficiencies, safety and compliance of processes and procedures (e.g., document management systems, electronic submissions)Organize and lead the communication and interaction with all regulatory agencies for all research and development projectsProvide expertise in translating regulatory requirements into practical and workable plansAdvise on regulatory matters for GMP, GLP and GCP aspects of all research and development functions (e.g., manufacturing and operations), pre-clinical and clinicalReview and approve documentation for clinical site participation in clinical studiesWork collaboratively across a broad range of people developing and maintaining good working relationships in order to facilitate a team based approach to meeting the company's objectivesStay current in the field and track the implication of trends relative to government regulatory activity in the US, Canada, Europe, Asia, Mexico, and Central and South America and provide analysis and interpretations of such regulations
REQUIREMENTS
B.S. degree in a scientific discipline is required, with advanced scientific degree, such as a PhD in biological sciences or M.D. highly preferredA minimum of 10-15 + years experience in the pharmaceutical industry in Regulatory Affairs requiredExpert knowledge of cGMPs and FDA regulations and experience working in a regulatory environment (FDA) is requiredDemonstrated ability to successfully interact with FDA reviewers on regulatory and scientific issuesSolid resource management and planning skillsSuccessful track record of hiring, training, and motivating teams to the highest level of performance