Senior Manager, Global CMC Regulatory Affairs

Essential Job Functions

• 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

Skills and Qualifications

• 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 a minimum of 5 years of pharmaceutical industry experience to include 5 years dedicated to CMC regulatory affairs matters; international experience preferred
• In depth knowledge of drug development, US and global CMC guidelines and regulations.

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 10% may be required to accomplish corporate goals and health authority requirements.