Associate Director, Regulatory Affairs: Job ID - 1435

Job Description

• Responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical, and CMC disciplines • Ensures timely preparation of organized and scientifically valid submissions • Provides expertise in translating regulatory requirements into practical, workable plans for project teams with international participants • May mentor and potentially supervise other regulatory professionals working on the project team and regulatory process-related topics • Requires ability to work strategically, both independently and in a team environment • The position will be based in Palo Alto, CA

Qualifications

• BS/BA Degree in a Scientific Discipline, Advanced Degree required • Minimum of 8 years overall regulatory experience, and preferably including experience managing investigational and marketed products • Prior experience representing Regulatory Affairs on cross-functional teams is desirable • Must be capable of effectively leading teams in preparation of submissions • Experience working on international teams desirable • Experience working on international submission desirable • Must have an extensive knowledge of regulatory requirements, including ICH and regional requirements, and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business • Must be capable of critically reviewing complex technical documents and influencing colleagues across functions • Experience with drug-device combination products preferred • Experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with marketing applications is a plus • Ability to travel up to 10-20% of the time domestically and internationally

Benefits

• Medical insurance • Vision insurance • Dental insurance • 401(k) • Paid maternity leave • Paid paternity leave • Commuter benefits • Disability insurance