Assoc Director, Regulatory Affairs CMC

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Job Description

JOB DESCRIPTION

The Associate Director CMC Regulatory Affairs Combination Products and Device is responsible for defining and advancing global CMC regulatory strategy for products platforms or major workstreams involving devices and combination products. This role ensures that regulatory strategy is integrated into development and lifecycle planning and that submissions are executed in a manner that supports approvability business objectives and continuity of supply. The Associate Director acts as a strategic partner across Pharmaceutical Development & Manufacturing (PDM) and cross-functional teams by translating complex technical development and regulatory considerations into clear regulatory pathways risk-based recommendations and executable plans.

This role is located in Foster City CA eligible for hybrid.

KEY RESPONSIBILITIES

• Define and lead global CMC regulatory strategy for device and combination product programs across development registration and lifecycle management
• Ensure regulatory strategy is integrated into cross-functional program plans and aligned with business objectives development milestones and supply considerations
• Lead global regulatory planning and oversight for complex global submissions and post-approval changes involving device and combination product content (IND/CTA NDA/BLA/MAA Notified Body Opinion)
• Provide strategic regulatory advice to PDM cross-functional stakeholders on development pathways design control considerations human factors and lifecycle approaches relevant to regulatory submissions
• Interpret and apply global regulations guidance and policy trends to shape regulatory strategies and support successful submissions and approvals
• Lead cross-functional evaluation of regulatory risks tradeoffs and mitigation plans and drive alignment on recommended paths forward
• Partner with global and regional regulatory colleagues to ensure coordinated strategy strong communication and market-specific readiness
• Play a lead role in preparation for health authority interactions including briefing materials strategic positioning and responses to agency questions relevant to combination products and devices
• Influence cross-functional stakeholders to anticipate regulatory implications early and incorporate them into development and lifecycle decisions
• Lead or contribute to initiatives that improve regulatory processes tools ways of working and knowledge management across the function
• Support building organizational awareness and knowledge build of combination products and devices and associated global regulatory landscape

QUALIFICATIONS:

Minimum Qualifications:

• A scientific degree with directly relevant professional experience in CMC device or combination product development and global regulatory affairs
  • 10 years with BA/ BS
  • 8 years with MA/ MS/ MBA
  • 5 years with PharmD/ PhD
• Significant experience leading development and submission management of regulatory filings ranging from routine to highly complex
• Strong knowledge of the global CMC regulatory landscape for devices and combination products including key market expectations and evolving regulatory trends
• Demonstrated ability to interpret technical CMC and device information and translate it into effective regulatory strategy
• Proven ability to influence cross-functional decision-making and operate as a strategic partner within complex development environments

Preferred Qualifications:

• Strong communication presentation and stakeholder management skills
• Demonstrated ability to lead through ambiguity manage competing priorities and guide teams through complex regulatory challenges

The salary range for this position is: $182070.00 - $235620.00. Gilead considers a variety of factors when determining base compensation including experience qualifications and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus discretionary stock-based long-term incentives (eligibility may vary based on role) paid time off and a benefits package. Benefits include company-sponsored medical dental vision and life insurance plans*.

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For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Required Experience:

Director