Sr Manager, Regulatory Affairs CMC, Combination Products and Device
About The Position
The Senior Manager, CMC Regulatory Affairs – Combination Products and Device is responsible for supporting CMC regulatory activities for development or lifecycle programs involving devices and combination products. This role supports the development and implementation of global regulatory strategy and is accountable for execution of high-quality regulatory submissions and lifecycle activities that support clinical development, product registration, and continued market supply. The Senior Manager partners closely with the Pharmaceutical Development & Manufacturing (PDM) team to ensure global regulatory requirements are incorporated into program planning and execution.
Requirements
- Undergraduate or advanced degree in life sciences or related field with significant CMC, manufacturing, device, development, regulatory, or related experience in the biopharma or related industry
- 8+ years with BA/ BS
- 6+ years with MA/ MS/ MBA
- 2+ years with PharmD/ PhD
- Experience supporting development and submissions management of regulatory filings, including experience leading routine to moderately complex CMC regulatory activities
- Working knowledge of global CMC regulatory requirements relevant to devices and combination products
- Ability to interpret technical information and translate it into clear regulatory actions and plans
- Strong collaboration, organizational, and project management skills
- Strong verbal, written, and presentation skills
- Demonstrated ability to work effectively across functions and influence without direct authority
Responsibilities
- Contribute to the development and implementation of global CMC regulatory strategies for development, registration, and lifecycle management of combination products
- Serve as the CMC Regulatory Affairs Combination Product and Device Lead for assigned device and combination product programs or workstreams
- Interpret and apply relevant global regulations, guidance, and evolving expectations relevant to devices and combination products to program work and strategy
- Provide regulatory input on device-related development activities, control strategy elements, design control documentation, and lifecycle changes needed to support regulatory submissions
- Support preparation and submission of high-quality CMC regulatory content for global submissions, including investigational, marketing applications, and post-approval submissions (IND/CTA, NDA/BLA/MAA, Notified Body Opinion)
- Partner with cross-functional stakeholders to support submission readiness, timeline execution, and resolution of CMC regulatory risks and issues
- Identify, communicate, and escalate regulatory risks or issues that may affect development, approval, or supply continuity
- Support health authority interactions through preparation of background packages, responses to agency questions, and follow-up actions
- Conduct regulatory impact assessments driven by lifecycle management of marketed combination products
- Maintain current knowledge of regulatory trends for devices and combination products and communicate relevant updates to project teams
- Support areas of priority to Gilead in policy/trade organization working groups for combination products
- Contribute to process improvement and operational excellence initiatives within CMC Regulatory Affairs
- Demonstrate and model Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities, as applicable
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
