Sr Director, Regulatory Affairs Strategy
$226,500–$317,100 year
HybridIrvine, California, United States
Job Summary
Lead regulatory strategy and lifecycle management for complex assets, overseeing major US and global submissions, filing execution, and post-approval change strategies. Collaborate with cross-functional stakeholders to drive development acceleration, mitigate regulatory risk, and enable efficient pathways with global health authorities. Represent regulatory affairs in governance, develop regulatory intelligence and influence management at the portfolio level, and establish best practices across R&D functions. Provide strategic leadership for business development due diligence and mentor regulatory strategists from first-in-human through approval. Accountable for all US regulatory submissions and approvals for assigned projects while maintaining continuous compliance in US and international markets.
Required Qualifications
- at least 15 years of regulatory affairs experience in the US and ex-US environments
- higher degree (MS, Ph.D. or PharmD) in a scientific discipline
- In-depth understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
- strong leadership and interpersonal skills, both written and verbal
- Some travel may be required – up to 20%
Desired Qualifications
- Ability to thrive in a fast-paced, entrepreneurial environment
- high attention to detail and ability to coordinate and prioritize assigned projects
- Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals
- Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning
- Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results
- Demonstrates strong business acumen by anticipating market dynamics and using financial and strategic insight to guide investments, manage risk, and align priorities with long-term organizational value
- Demonstrates an innovative mindset by championing new ideas, investing in enabling systems and partnerships, and translating innovation into sustainable growth and organizational resilience
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