Assoc Director, Regulatory Affairs CMC
About The Position
The Associate Director, CMC Regulatory Affairs – Combination Products and Device defines and advances global CMC regulatory strategy for products, platforms, and major workstreams involving devices and combination products. The role integrates regulatory strategy into development and lifecycle planning and oversees submissions to support approvability, business objectives, and continuity of supply. It partners with Pharmaceutical Development & Manufacturing (PDM) and cross-functional teams, translating technical, development, and regulatory considerations into pathways, risk-based recommendations, and executable plans. The position leads strategy and regulatory planning for global submissions and post-approval changes; advises stakeholders on development pathways, design controls, human factors, and lifecycle approaches; and interprets global regulations and policy trends. It also drives cross-functional alignment on risks and mitigation, coordinates with global and regional regulatory colleagues, leads preparation for health authority interactions, and supports improvements to regulatory processes and organizational knowledge of combination products and devices.
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.
- Ability to interpret technical CMC and device information and translate it into effective regulatory strategy.
- Ability to influence cross-functional decision-making and operate as a strategic partner in complex development environments.
- Strong communication, presentation, and stakeholder management skills.
- 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.
- Integrate regulatory strategy into cross-functional program plans and align it with business objectives, development milestones, and supply considerations.
- Lead global regulatory planning and oversight for complex 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 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 coordinate strategy, communication, and market-specific readiness.
- Lead preparation for health authority interactions, including briefing materials, strategic positioning, and responses to agency questions concerning combination products and devices.
- Influence cross-functional stakeholders to anticipate regulatory implications and incorporate them into development and lifecycle decisions.
- Lead or contribute to initiatives that improve regulatory processes, tools, ways of working, and knowledge management.
- Support organizational awareness and knowledge-building regarding combination products, devices, and the associated global regulatory landscape.
Benefits
- The position may be eligible for a discretionary annual bonus.
- The position may be eligible for discretionary stock-based long-term incentives; eligibility may vary by role.
- Paid time off.
- Company-sponsored medical, dental, vision, and life insurance plans.
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What This Job Offers
Job Type
Full-time
Career Level
Director
