Sr. Manager, Regulatory Operations

Overview

The Senior Manager, Regulatory Operations is responsible for overseeing the company’s regulatory operations function and ensuring that regulatory information systems align with organizational goals. This role plays a key part in driving cross-functional regulatory initiatives and fostering collaborative relationships across departments.

Responsibilities

• Identify and resolve issues affecting submission timelines; drive process efficiency and ensure high-quality, timely submissions.
• Ensure submission archives and lifecycle documentation are maintained according to company standards and regulatory requirements.
• Lead the review and maintenance of labeling content for new products, line extensions, and label updates.
• Develop, review, and manage contracts and service agreements with regulatory consultants, vendors, and third-party partners.
• Lead planning, tracking, and forecasting of budgets for regulatory activities.
• Support vendor sourcing, RFP processes, and contract negotiations to secure cost-effective regulatory services.
• Collaborate with Finance and Legal teams to ensure timely contract execution, budget reconciliation, and invoice processing.
• Track regulatory project costs, milestones, and invoicing; flag variances and recommend corrective actions.
• Maintain internal systems to organize agreements, budgets, and correspondence.
• Monitor global regulatory policies, guidance, legislation, and agency announcements that impact the company’s product portfolio.
• Maintain a centralized repository for regulatory intelligence, including updates, timelines, and impact assessments.
• Lead continuous improvement initiatives in regulatory operations, including SOP development and training.

Qualifications

• Bachelor’s degree in a scientific discipline required.
• 5+ years of progressively responsible experience in Regulatory Affairs.
• Strong knowledge of regulatory business operations, budgeting, and vendor/contract management.
• Proficient in Microsoft Excel and regulatory and contract management platforms; experience with Veeva Systems and HighQ preferred.
• Competencies: Teamwork & Collaboration, Attention to Detail, Negotiation skills, Problem Solving, Organizational skills, Written and Verbal Communications
• Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. This is a hybrid role based in Xeris’ Chicago office and requires a minimum of three days per week in the office. On-site requirement may change at management’s discretion.

 

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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 $110,000 to $200,000. 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.