Senior Manager/Associate Director, Regulatory Affairs (13-120) FibroGen
THIS JOB HAS EXPIRED Description:
Review, provide comments on, and prepare documents for submission to FDA and international regulatory authorities including protocols, investigator brochures, nonclinical and CMC amendments, and other regulatory documents.
Lead teams on the preparation, review and finalization of Annual Reports.
Assist teams with the development, review, and finalization of briefing documents to FDA or health authorities, conduct meeting rehearsals, and participate in regulatory meetings.
Function as the primary contact with FDA and international regulatory authorities.
Provide regulatory guidance and strategy to assigned project teams
Lead working groups responsible for the development of regulatory submissions; interact with other team members to ensure timely preparation and receipt of information required for regulatory submissions.
For ex-US submissions to Thailand, Singapore, Hong Kong, or other ASEAN countries, lead and prepare submissions including CTCs, CTA, amendments and notifications.
Understand and identify potential regulatory risks and implications for ongoing and new projects, be proactive in identifying solutions to mitigating the risks and work effectively with team members and senior management to resolve them.
Scientific background (minimum BS degree or equivalent in the life sciences) with at least five years experience in regulatory affairs; experience with biological products preferred.
Thorough understanding of current and evolving FDA, ICH and other appropriate regulations and guidance.
Experience with the preparation of INDs and amendments, and NDAs/BLAs; experience with submissions in CTD format preferred.
Leadership and management skills with the ability to manage simultaneous priorities and changing deadlines.
Excellent oral and written communication skills.
Excellent planning, organizational and prioritizing skills.
Proficiency in the use of MS Word, PowerPoint; experience with Adobe Acrobat Professional; experience with electronic publishing systems.
||San Francisco, CA |
THIS JOB HAS EXPIRED