Xeris Pharmaceuticals, Inc. · 21 hours ago
Associate Director, Global CMC Regulatory Affairs
Chicago, IL
Full-time
Hybrid
Lead/Staff, Director/Executive
$170K/yr - $220K/yr
10+ years expXeris Pharmaceuticals, Inc. is seeking an Associate Director of CMC Regulatory Affairs who will be responsible for creating and executing CMC regulatory development plans. The role involves leading CMC regulatory initiatives, providing expertise, and engaging with regulatory agencies while managing tight timelines.
BiotechnologyDiabetesHealth CarePharmaceuticalTherapeutics
Responsibilities
Serve as Global Chemistry, Manufacturing and Controls (CMC) regulatory leader for products at various stages of development
Prepare Global CMC part of 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
Qualification
Required
B.S. in a scientific discipline required, B.S. in chemistry, pharmaceutical sciences or similar discipline preferred
Diverse technology experience (small molecules, biologics, parenteral and oral dosage forms)
Must have 10-15 years pharmaceutical industry experience in regulatory affairs with at least 5 years dedicated to CMC regulatory affairs matters; international experience preferred
In depth knowledge of drug development, US and global CMC guidelines and regulations
Positive attitude, energetic and proactive
Competencies : Functional Leadership skills, Negotiation skills, Teamwork & Collaboration, Attention to Detail, Self-Starter, Problem Solving, Organizational skills, Adaptability, Professionalism, Written and Verbal Communications, Analytical skills
Working Conditions : This is a hybrid position based in Xeris' Chicago office and a minimum of three days per week on-site is required. On-site requirement may change at management's discretion. Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Travel up to 25% may be required to accomplish corporate goals and health authority requirements
Benefits
Bonus
Equity
Multiple paid time off benefits
Various health insurance options
Retirement benefits
Company
Xeris Pharmaceuticals, Inc.
We're a growth-oriented biopharmaceutical company improving patient lives by developing and commercializing advanced products across a range of therapies.
201-500 employees
H1B Sponsorship
Xeris Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$548.5MKey Investors
Hayfin Capital ManagementArmistice CapitalDeerfield
2024-03-06Post Ipo Debt· $200M
2022-01-03Post Ipo Equity· $30M
2021-03-11Post Ipo Equity· $27M
Leadership Team
John Shannon
CEO and Director
Kenneth Johnson
Senior Vice President - Clinical Development, Regulatory Affairs, QA and Medical Affairs
Recent News
2026-01-09
The Motley Fool
2026-01-03
Company data provided by crunchbase