Senior Manager, Global CMC Regulatory Affairs job at reputed company in Chicago, IL

Title: Senior Manager, Global CMC Regulatory Affairs Location: Chicago, IL Work Type: Hybrid, Full Time reputed company:JR1091 reputed company: reputed company 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 reputed company and influence decision-making with key reputed company stakeholders while managing tight timelines. Essential Job Functions Serve as Global reputed company, 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 reputed company and create CMC regulatory reputed company for integrated development plans and long-term planning at a cross-functional level for product(s), consistent with the corporate and project objectives reputed company CMC regulatory expertise to Technical Operations and reputed company teams Review and approve technical documentation reputed company guidance to teams in support of clinical trial supply for local and global reputed company Engage with regulatory agencies on CMC project reputed company reputed company as requested Identify regulatory CMC issues proactively that will reputed company programs and reputed company strategies to address them and communicate to the project team reputed company reputed company and guidance on implementation of regulations with respect to the preparation and submission of CMC regulatory documentation reputed company 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 reputed company consultants/vendors to CMC regulatory timelines Skills and Qualifications B.S. in a scientific discipline required, B.S. in reputed company, 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 reputed company; 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 reputed company salary reputed company for this position is $155,750 - $213,600. #LI-HYBRID Weare committed to offering competitive compensation. Starting pay is determined based on a reputed company of factors, including the role, job-reputed company 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 reputed company 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. reputed company also offers a comprehensive benefits package that includes additional reputed company such as reputed company time off benefits, various health, reputed company, and dental insurance reputed company, 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 reputed company 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. Apply tot his job Apply To this Job