Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1998

United States·Palo AltoFull-timeexecutive

OtherRegulatory Affairs

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Quick Summary

Technical Tools

OtherRegulatory Affairs

What We Offer

~1 min read

The 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.

✓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

Responsibilities

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→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.
→Work is performed under direction of a Senior Regulatory Affairs professional.

Requirements

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Minimum of 10 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.
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, but not required.
Ability to travel up to 10-20% of the time domestically and internationally.
Must have experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with BLAs/NDAs/MAAs a plus.

The estimated salary range for this position is $215-240K 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.