Senior Manager, Global CMC Regulatory Affairs

Job Purpose
- Create CMC regulatory development plans and execute against them. Represent CMC Regulatory Affairs on departmental and cross-functional initiatives.

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 CMC regulatory strategy for integrated development plans and long-term planning cross-functionally.
- Provide CMC regulatory expertise to Technical Operations and Quality; review and approve technical documentation.
- Guide teams supporting clinical trial supply for local and global clinical trials.
- Engage with regulatory agencies on CMC matters as requested.
- Proactively identify CMC regulatory issues, develop strategies, and communicate to the project team.
- Provide guidance on implementation of regulations for preparation and submission of CMC regulatory documentation.
- Drive cross-functional decision-making on CMC regulatory issues; create submission timelines with cross-functional teams.
- Manage internal teams and external consultants/vendors to meet timelines.

Qualifications / Skills
- B.S. in a scientific discipline required (chemistry/pharmaceutical sciences preferred).
- Minimum 5 years pharmaceutical industry experience, including 5 years CMC regulatory affairs (international experience preferred).
- In-depth knowledge of drug development and US/global CMC guidelines and regulations.
- Competencies: functional leadership, negotiation, collaboration, attention to detail, self-starter/problem solving, organization, adaptability, professionalism, written/verbal communications, analytical skills.

Compensation
- Anticipated base salary range: $155,750–$213,600.

Application instructions (accessibility)
- For reasonable accommodations, email recruiting@xerispharma.com with the job requisition number and request details (no medical/health info).