Job Description

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.

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

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 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 managements 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.

As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.

The anticipated base salary range for this position is $170,000 to $220,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. 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. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

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Job Tags

Full time, Work at office, Local area, Night shift, Weekend work, Afternoon shift, 3 days per week,

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