Senior Manager, Global CMC Regulatory Affairs

Xeris Pharmaceuticals Inc; Georgia; Híbrido; USD 134 000 - 214 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Equity or long-term incentive awards

Annual bonus

401(k) retirement benefits

Comprehensive benefits package

Resumo da oferta

Xeris Pharmaceuticals Inc. is seeking a Senior Manager of CMC Regulatory Affairs to drive global CMC strategy and manage regulatory submissions across INDs, NDAs, MAAs, and CTAs. The role requires coordinating with Technical Operations, Quality, and external partners to ensure compliant, timely deliverables.

The position is hybrid, based in the Chicago area with travel as needed and a base salary range of $133,500–$213,600, reflecting market norms for senior regulatory leadership in biopharma.

Qualificações

• Minimum of 5 years in the pharmaceutical industry with 5 years in CMC regulatory affairs.
• International experience preferred.
• In-depth knowledge of US and global CMC guidelines and regulations.

Responsabilidades

• Lead as Global CMC regulatory leader for assigned products and prepare global CMC content for regulatory filings.
• Develop CMC regulatory strategies for integrated development plans and cross-functional alignment.
• Provide regulatory expertise to Technical Operations and Quality teams and review technical documentation.
• Engage with regulatory agencies on CMC matters and drive cross-functional decision making.
• Create submission timelines with cross-functional teams and manage internal/external resources.

Conhecimentos

Functional Leadership

Negotiation

Teamwork

Attention to Detail

Self-Starter

Problem Solving

Organizational Skills

Adaptability

Professionalism

Communication

Analytical Skills

Formação académica

B.S. in a scientific discipline

Descrição da oferta de emprego

Job Overview

The Senior Manager of CMC Regulatory Affairs will be responsible for creating CMC regulatory development plans and for successful execution against those plans. The Senior Manager of CMC Regulatory Affairs represents the function on departmental and cross-functional initiatives. The Senior Manager must be articulate and influence decision-making with key internal and external stakeholders while managing tight timelines.

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.

Salary

The anticipated base salary range for this position is $133,500 - $213,600. #LI-HYBRID We are committed to offering competitive compensation. Starting pay is determined based on a variety of factors, including the role, job-related knowledge, skills, experience, education, internal equity, market data, and the location of the role, where applicable.

Benefits

• Employees are eligible for equity or long-term incentive awards, where applicable.
• Field Sales role employees are eligible for a quarterly commission structure.
• Non-Sales role employees are eligible for an annual bonus.
• The Company also offers a comprehensive benefits package that includes additional elements such as paid time off benefits, various health, vision, and dental insurance options, 401(k) retirement benefits and more for eligible employees.

Accessibility & Reasonable Accommodations

If, because of a medical condition or disability, you require a reasonable accommodation or assistance to complete any part of the application process, please send an e-mail to [e-mail] and identify the type of accommodation or assistance you are requesting. Please include the job requisition number in your message. Please note if your request is not for this stated purpose, you will not receive a response to your email. Do not include any medical or health information in this e-mail.

Equal Employment Opportunity

Xeris Pharmaceuticals, Inc. (the "Company") is an equal opportunity employer and does not discriminate based on race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. All qualified candidates are given equal opportunity and the Company's employment selection decisions are based solely on job-related factors.

Company Culture

Xeris is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris is headquartered in Chicago, Illinois and has a strong foundation built on proprietary formulation technologies and deep expertise in clinical development and commercialization. Xeris participates in E-Verify.