Xeris Pharmaceuticals
Associate Director, Global CMC Regulatory Affairs
Xeris Pharmaceuticals, Chicago, Illinois, United States, 60290
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 management’s 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.
#J-18808-Ljbffr
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 management’s 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.
#J-18808-Ljbffr