Job Description:
The Senior Manager, Regulatory Affairs is responsible for managing regulatory activities supporting global clinical development programs across all phases. This role independently plans, prepares, and manages regulatory submissions, contributes to regulatory strategy development, and serves as a key regulatory representative on cross-functional teams. The Senior Manager partners with internal stakeholders to ensure timely, high-quality regulatory submissions that comply with global health authority requirements while supporting the successful execution of development programs.
The ideal candidate has a strong understanding of global regulatory requirements, demonstrates sound regulatory judgment, and is capable of managing multiple complex projects with minimal supervision.
Essential Job Functions
- Independently lead and coordinate the preparation, review, and submission of clinical regulatory documents (e.g., INDs, CTAs, amendments, annual reports).
- Contribute to the development and execution of regulatory strategies for clinical-stage programs.
- Collaborate with Clinical Operations, Medical Writing, and other internal functions to review and compile documentation for regulatory submissions (e.g., protocols, investigator brochures, clinical study reports).
- Review clinical development documents, including protocols, investigator brochures, informed consent forms, and clinical study reports, to ensure regulatory requirements are appropriately addressed.
- Identify regulatory risks and escalate issues with proposed solutions to regulatory management.
- Ensure regulatory submissions comply with applicable regulations, guidance documents, and internal standards.
- Coordinate submission timelines, deliverables, and regulatory activities to support development milestones.
- Contribute to health authority interactions, including the preparation of meeting briefing documents and responses to information requests.
- Evaluate emerging regulatory guidance and communicate relevant changes and potential impacts to project teams.
- Ensure accuracy and completeness of regulatory content in submission archives and tracking systems.
Skills and Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field..
- 5+ years of experience in the pharmaceutical or biotechnology industry with a strong focus on clinical development.
- Demonstrated experience preparing and managing global regulatory submissions, including INDs, CTAs, amendments, and annual reports.
- Working knowledge of global regulatory requirements and guidelines, including FDA, EMA, ICH, and GCP.
- Experience supporting health authority interactions and regulatory correspondence.
- Strong project management and organizational skills with the ability to manage multiple priorities independently.
- Excellent written and verbal communication skills with the ability to clearly communicate scientific and regulatory information.
- Demonstrated ability to work effectively in cross-functional teams and influence outcomes through collaboration.
- Experience with regulatory document management systems (e.g. Veeva Vault) is desirable.
Working Conditions
- Preference will be given to Chicagoland-based candidates. For those living in the Chicagoland area, this is a hybrid position based in Xeris’ Chicago office. 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.
The anticipated base salary range for this position is $155,750 to $213,600.
#LI-REMOTE
Direct Employers Posting: Nationwide Remote
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.
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. NOTE: This job description is not intended to be all-inclusive. The employee may be required to perform other related duties as needed to meet the ongoing needs of the Company.
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 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 [email protected] 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.
Xeris participates in E-Verify. E-Verify Participation Poster
EEO is the Law EEO is the Law
EEO is the Law Supplement EEO is the Law Supplement
Pay Transparency Nondiscrimination Provision Pay Transparency Nondiscrimination Provision
Skills Required
- Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
- 5+ years of experience in the pharmaceutical or biotechnology industry with a strong focus on clinical development.
- Demonstrated experience preparing and managing global regulatory submissions, including INDs, CTAs, amendments, and annual reports.
- Working knowledge of global regulatory requirements and guidelines, including FDA, EMA, ICH, and GCP.
- Experience supporting health authority interactions and regulatory correspondence.
- Strong project management and organizational skills with the ability to manage multiple priorities independently.
- Excellent written and verbal communication skills.
- Demonstrated ability to work effectively in cross-functional teams and influence outcomes through collaboration.
- Experience with regulatory document management systems (e.g. Veeva Vault).
- Preference for Chicagoland-based candidates; hybrid role with minimum three days per week on site for local hires.
What We Do
We're a growth-oriented biopharmaceutical company improving patient lives by developing and commercializing advanced products across a range of therapies.
