Associate Director, Global CMC Regulatory Affairs

1w1 week ago

Xeris Pharmaceuticals, Inc.

Chicago, US · Full-time · $170,000 – $220,000

About this role

The Associate Director of CMC Regulatory Affairs creates CMC regulatory development plans and ensures successful execution against those plans. This role represents the function on departmental and cross-functional initiatives. Must be articulate to influence decision-making with key internal and external stakeholders while managing tight timelines.

Serves as Global CMC regulatory leader for products at various stages of development. Prepares Global CMC parts of INDs, NDAs, MAAs, IMPDs, CTAs, annual reports, and other regulatory documents. Develops CMC regulatory strategy for integrated development plans consistent with corporate objectives.

Provides CMC regulatory expertise to Technical Operations and Quality teams. Reviews and approves technical documentation. Offers guidance for clinical trial supply in local and global trials while engaging regulatory agencies on CMC matters.

Proactively identifies regulatory CMC issues impacting programs and provides strategies to address them. Drives decision-making in cross-functional teams on CMC regulatory issues. Manages internal teams and external consultants to meet CMC regulatory 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)
10-15 years pharmaceutical industry experience in regulatory affairs with at least 5 years dedicated to CMC regulatory affairs; 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 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 CMC regulatory strategy for integrated development plans and long-term planning at cross-functional level
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
Identify regulatory CMC issues proactively and provide strategies to address them

Benefits

Hybrid position based in Chicago office with minimum of three days per week on-site
Periodic evening and weekend work as necessary to fulfill obligations
Periodic overnight travel up to 25% to accomplish corporate goals and health authority requirements