Director, Regulatory Affairs 9/7/2016
San Francisco, CA
JOB DESCRIPTIONAPPLY Director, Regulatory Affairs - San Francisco Bay Area Prepare regulatory filings and regulatory requirements; Review of clinical documents.
* Manage the operations of the Regulatory Affairs department, allocate resources and coordinate the activities of personnel
* Develop resource plans for company regulatory submission projects, including budgets, capital equipment expenditures
* Effectively engage with regulatory agencies worldwide
* Prepare project/study team for FDA and other regulatory health agency meetings, as required
* Lead the preparation of submissions, which may include INDs, Briefing Documents, Drug Applications, and Marketing Applications, etc.
* Work with cross-functional teams to define contributions to submissions and then lead regulatory submission teams
* Review submissions for accuracy and verification of pre-clinical, clinical, and Nonclinical data
* Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines
* Maintain regulatory expertise and serve as internalconsultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent
* Ensure effective department procedures, including creating and reviewing SOPs as needed
* Provide regulatory due diligence and regulatory advice for potential new product opportunities
* Supervise and mentor direct reports
* Develop regulatory strategies aimed at achieving marketing authorization and appropriate product labeling
* Serve as primary regulatory representative for cross-functional teams and lead regulatory sub-teams
* Serve as primary liaison with regulatory authorities
* Experience in oncology and/or hematology
* Ph.D. degreepreferred and 8-10+ years of direct regulatory affairs experience within the pharmaceutical /biotech industries
* 5+ years of leadership, supervisory or management experience
* Direct experience in the submission of product license applications to the FDA and other international regulatory agencies
* Results-oriented with an enthusiastic attitude, strong leadership and interpersonal skills and a solid understanding of the drug discovery and development processes
* A thorough understanding of FDA and International regulations
* Strong leadership, communication, project management and presentation skills
* Experience and knowledge in preparation of essential regulatory documentation including but not limited to INDs, NDAs, etc. and other supportive amendments and product approval supplements
* Thorough knowledge of the drug development process, with a focus on IND and NDA processes.
* Demonstrated experience in preparing new IND and/or NDA submissions.
* Results driven and team-orientated with the ability to influence outcomes as necessary skills in the environment.
* Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
* Must be able to innovate, analyze and solve problems with minimal supervision and exceptionally keen skills for attention to detail.
* Excellent communication skills. Ability to lead and communicate orally, in written documents, and in formal presentations is required
* Biologics, Oncology, and/or hematology, solid tumor, experience is a plus.
_This job description is subject to change._