Associate Director, Global CMC Regulatory Affairs

Xeris Pharmaceuticals • Chicago, IL

1d • Hybrid

About The Position

Overview The Associate Director of CMC Regulatory Affairs will be responsible for creating CMC regulatory development plans and for successful execution against those plans. The Associate Director of CMC Regulatory Affairs represents the function on departmental and cross-functional initiatives. The Associate Director 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, 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
• Functional Leadership skills, Negotiation skills, Teamwork & Collaboration, Attention to Detail, Self-Starter, Problem Solving, Organizational skills, Adaptability, Professionalism, Written and Verbal Communications, Analytical skills.

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

Benefits

• This role will include eligibility for bonus and equity.
• The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 251-500 employees