Senior Manager, Global CMC Regulatory Affairs
Xeris Pharmaceuticals•Chicago, IL
•Hybrid
About The Position
The Senior Manager of CMC Regulatory Affairs will be responsible for creating CMC regulatory development plans and for successful execution against those plans. The Senior Manager of CMC Regulatory Affairs represents the function on departmental and cross-functional initiatives. The Senior Manager must be articulate and influence decision-making with key internal and external stakeholders while managing tight timelines.
Requirements
- B.S. in a scientific discipline required
- Must have a minimum of 5 years of pharmaceutical industry experience to include 5 years dedicated to CMC regulatory affairs matters
- In depth knowledge of drug development, US and global CMC guidelines and regulations
Nice To Haves
- B.S. in chemistry, pharmaceutical sciences or similar discipline preferred
- Diverse technology experience (small molecules, biologics, parenteral and oral dosage forms)
- international experience preferred
Responsibilities
- Serve as Global Chemistry, Manufacturing and Controls (CMC) regulatory leader for assigned products
- Prepare Global CMC content for INDs, NDAs, MAAs, IMPDs, CTAs, annual reports, and other regulatory documents
- Develop and create CMC regulatory strategy for integrated development plans and long-term planning at a cross-functional level for product(s), consistent with the corporate and project objectives
- Provide CMC regulatory expertise to Technical Operations and Quality teams
- Review and approve technical documentation
- Provide guidance to teams in support of clinical trial supply for local and global clinical trials
- Engage with regulatory agencies on CMC project related matters as requested
- Identify regulatory CMC issues proactively that will impact programs and provide strategies to address them and communicate to the project team
- Provide insight and guidance on implementation of regulations with respect to the preparation and submission of CMC regulatory documentation
- Drive decision making in the cross functional teams with respect to CMC regulatory issues
- Create CMC regulatory submission timelines in collaboration with cross functional teams
- Manage internal team and external consultants/vendors to CMC regulatory timelines
Benefits
- paid time off benefits
- various health, vision, and dental insurance options
- 401(k) retirement benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
