The Senior Manager, Regulatory Operations provides business critical insights using analytics, ensures cross functional alignment of goals, and helps teams execute corporate objectives. This position provides oversight across internal and external teams for regulatory submissions and procedures, and is responsible for developing and directing strategy, objectives, and policies pertaining to developmental and marketing submissions to domestic and foreign health authorities. This position stays focused on aligning the highest-level company priorities with strong day-to-day operations involvement and helps evolve early stage ideas into future-growth initiatives.
• Manage and coordinate preparation of IND, CTA, NDA, BLA, MAAs. • Manage and support post-approval activities, including labeling-promotion submissions (Form 2253), labeling changes, safety reporting, and pharmacovigilance updates. • Independently function as Veeva RIM in-house expert. Manage and maintain all activity in the Veeva RIM Vault to keep records up to date and submissions on track with company goals. • Create label artwork using Adobe Illustrator. • Plan and coordinate preparation of Investigator Brochures (IBs), Clinical Study Reports (CSRs), Protocols and Annual Reports to maintain corporate timelines. • Upload and maintain drug listings on FDA’s website for all appropriate applications. • Original and lifecycle management of regulatory submissions in eCTD format. • Provide deep expertise on current regulatory publishing standards and requirements. • Works in conjunction with product development team members to develop processes for the creation of electronic submission-ready documents. • Provide technical review of critical components for accuracy, compliance with Health Authority requirements, and internal standards • Provide final Quality Control review of all published dossiers prior to submission to health authorities. • Coordinate and provide oversight of third-party contractor support for regulatory submissions, such as regulatory experts, medical writing, data management, and statistics. • Assemble and coordinate required resources/teams in alignment with strategic regulatory plans by driving cross-functional alignment to ensure quality, manufacturing, planning, compliance, and operational requirements are met to move through progressive milestones. • Coordinate Drug Safety reports to ensure compliance with strict submission deadlines. • Support project teams by engaging in monitoring of regulatory progress at each stage of development to inform capacity, cost, and fit with long term regulatory strategy. • Support budget management for the Regulatory department quarterly to ensure all spending is captured and manage the creation of POs. • Proactively manage, monitor, and adjust plans throughout the project to keep the program on target. • Manage conflicts and escalate critical issues to the project sponsor. • Create and implement a communications plan to keep team members, stakeholders, and sponsors up to date on project status and issues. • Flexibly contribute to other project roles, as necessary
Bachelor’s degree, preferably in a scientific field such as biochemistry or biology; relevant experience may be substituted.
Minimum 5 years of regulatory experience in the pharmaceutical
Experience with regulatory operations and planning
Demonstrated stakeholder management capability and ability to effectively collaborate across the organization; interact within and across the matrix to manage
Understanding of operational and regulatory aspects of biopharma
Sophisticated competency with Veeva systems, Global Submit, and Rosetta Phoenix.
Fluency with Adobe Illustrator
Competencies: Problem Solving, Critical Thinking, Conflict Resolution, Confidentiality, Verbal & Written Communication skills, Presentation skills, Teamwork & Collaboration, Self-Starter
Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
Where permitted by applicable law, must have received or be willing to receive the COVID-19 vaccine by date of hire to be considered for U.S.-based job.
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.