Director of Regulatory Affairs

About us -
Bionovo, Inc. is a pharmaceutical company focusing on the discovery and development of drugs for cancer and women's health. As part of the Bionovo team, each of our employees is recognized as a valuable member of the collaborative effort to reach our shared goals. Together, we have created a working environment that is entrepreneurial, professional, challenging and exciting. We are currently looking for a qualified individual to join our Emeryville, CA team.

 

The job ? Director of Regulatory Affairs

 Provide regulatory advice and guidance to ensure regulatory programs and submissions meet domestic and international regulatory requirements. Manage and ensure compliance with reporting requirements to FDA and International regulatory bodies. Request, review and interpret for clarity, accuracy and completeness IND/NDA/Safety Annual Report components, and compile and submit the reports to the FDA within the specified time frame.Work closely with preclinical, clinical and CMC groups, from the initial process of defining regulatory requirements and strategies to the final approval of reports and their inclusion in the regulatory submission documentation. Assist in reporting and follow-up of all adverse drug experiences received by Bionovo.Coordinate preparation of FDA meeting briefing packages.Interface with all Bionovo team members to ensure timely submissions and to oversee the support of all filings. Serve as primary liaison between the company and FDA Project Managers and Reviewers for individual projects. Prepare for key meetings with the FDA and other regulatory authorities. Understanding of worldwide regulatory requirement and guidelines, to develop strategies for worldwide registration of products and management of implementation.Review and approve scientific and promotional materials.Review clinical investigation-related documents for accuracy and compliance with GCPs (study protocol, investigator brochure, informed consent, etc.).Maintain up-to-date knowledge of FDA requirements. Participate in the hiring, training and development of staff.Required Travel: Up to 25%.

 

Benefits -We offer a competitive benefits package plus stock options.

Qualifications ?

 Bachelor's degree is required. Scientific/health care field preferred, but not required. Regulatory Affairs Certificate (RAC) highly desired. Previous management experience.Experience with FDA submissions, including INDs and NDAs. Experience with international regulatory requirements. Experience with electronic submissions a plus.Working knowledge of FDA regulations and requirements for INDs, NDAs, DMFs, CTAs and MAAs. Ability to read, analyze and interpret scientific and technical journals, as well as regulatory documents.Strong ability to think analytically, strategically and independently.Strong ability to lead others.Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.Excellent interpersonal skills and strong ability to effectively operate in team situations.Excellent problem-solving skills.Must be able to work in a fast-paced environment with demonstrated ability to effectively handle multiple competing tasks and demands.Excellent ability to establish sound working relationships with people in a wide variety of disciplines and backgrounds.Ability to communicate effectively with contract organizations and respond to inquiries or complaints.Excellent verbal/written communication skill. Proficiency in using the Internet and Microsoft Word, PowerPoint, Access, Outlook and Excel.

 

Apply ?

To immediately respond to this opportunity, please apply on line at:  

http://www.MyChoiceEngine.com/Role/26672

 

EOE.