Job Description:Job PurposeThe 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.
The anticipated base salary range for this position is $155,750 - $213,600.
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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.
The level of the position will be determined based on the selected candidate's qualifications and experience. Final determination of the actual base salary offered depends on several factors, including but not limited to the candidate's skills, experience, education, location, and business needs. 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. 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. Individuals hired as temporary employees, interns, and preceptors are not eligible for commissions, bonuses, and/or long-term incentive or equity awards. Eligibility for other benefits will be based on plan documents.
Accessibility & Reasonable AccommodationsIf, 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 [redacted] 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 email.
