Assoc Director, Regulatory Affairs CMC

Gilead Sciences•Foster City, CA

3d•$182,070 - $235,620

About The Position

The Associate Director, CMC Regulatory Affairs – Combination Products and Device defines and advances global CMC regulatory strategy for products, platforms, or major workstreams involving devices and combination products. The role integrates regulatory strategy into development and lifecycle planning and ensures submissions support approvability, business objectives, and continuity of supply. Acting as a strategic partner across Pharmaceutical Development & Manufacturing (PDM) and cross-functional teams, the Associate Director translates complex technical, development, and regulatory considerations into clear regulatory pathways, risk-based recommendations, and executable plans. The role also contributes to regulatory process improvement and organizational knowledge of combination products, devices, and their global regulatory landscape.

Requirements

A scientific degree with directly relevant professional experience in CMC, device or combination product development, and global regulatory affairs.
At least 10 years of experience with a BA/BS, 8 years with an MA/MS/MBA, or 5 years with a 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.
Strong communication, presentation, and stakeholder management skills.
Demonstrated ability to lead through ambiguity, manage competing priorities, and guide teams through complex regulatory challenges.

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, including IND/CTA, NDA/BLA/MAA, and 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 preparing 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 organizational awareness and knowledge-building about combination products and devices and the associated global regulatory landscape.