Associate Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1961

Position Summary

The Associate Director, Regulatory Affairs Clinical Strategy will be 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 both independently and in a team environment. The position will be based in Palo Alto, CA.

Key Responsibilities

• Responsible for strategic and operational regulatory input for cross functional (CMC, non-clinical and clinical) areas in collaboration with other project team members, including CMC regulatory team members
• Contributes to the development of global clinical and regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations
• Contributes to development of global labeling documents (prescribing information and patient information)
• Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs
• Maintains knowledge of highly complex regulatory requirements up to current date and communicates changes in regulatory information to project teams
• Schedules and arranges own activities and those of direct reports

Requirements

• Minimum of 8 years overall regulatory experience, and preferably including experience managing investigational and marketed products
• Bachelors Degree required
• 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
• 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
• Capable of critically reviewing complex technical documents and influencing colleagues across functions
• Experience with drug-device combination products preferred, but not required
• Experience with filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with BLAs/NDAs/MAAs a plus

Benefits

The estimated salary range for this position is $185-$205K DOE. Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package. Benefits include 401(k) plan with company match, medical, dental, and vision plans, company-offered Life and Accidental Death & Dismemberment (AD&D) insurance, company-provided short and long-term disability benefits, unique offerings of Pet Insurance and Legal Insurance, Employee Assistance Program, Employee Discounts, Professional Development Health Saving Account (HSA), Flexible Spending Accounts, various incentive compensation plans, accident, critical illness, and hospital indemnity insurance, mental health resources, paid leave benefits for new parents, and an inclusive environment for all employees.