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Director, Regulatory Operations

Company: Seres Therapeutics
Location: Somerville
Posted on: January 6, 2021

Job Description:

Seres is seeking a Director of Regulatory Operations to lead the submission activities for multiple products across their diverse portfolio. The chosen candidate will have the opportunity to break new ground and be part of filing and potentially winning approval for the first microbiome therapeutic in the United States.Director, Regulatory Operations will lead the regulatory operations function as well as cross-functional teams in the successful delivery of Regulatory submissions for all development programs and projects. This person will be accountable for ensuring health authority submissions are compiled accurately, in their entirety, within specified timelines while maintaining quality. This person will be responsible for leading the collaboration with Seres staff, as well as external vendors, regarding health authority submission logistics (content, deliverable timing, status, issue resolution, review and QC). This includes recording and tracking content and eCTD lifecycle of all applications, ensuring proper archiving of each submission, and providing eCTD/submission guidance and training to Seres staff.Essential Responsibilities:Leads the submission planning efforts for all development programs.Works closely with Regulatory Affairs to effectively identify, plan for and manage timely completion of development programs regulatory milestones.Sets priorities on upcoming submissions to health authorities and maintains status of assigned submissions. Prepares and manages the Health Authority Application Tracker as appropriate.Manages regulatory budgets to support all phases of drug development projects.Closely interacts with team members and authoring community to define submission logistics, scheduling and priorities.Set and manage expectations, highlighting and resolving issues, ensuring regular communications and managing internal and external activities. Supports Development Teams in understanding the document requirements for Health Authority submissionsManage Management System for all regulated documents to ensure proper lifecycle management, to track and monitor development programs regulatory objectives/goals, archival and storage of regulatory submissions.Manage and track the internal review of larger Health Authority applications to ensure accuracy/completeness prior to submission. This includes maintaining constant communication with internal team and eCTD vendor to ensure timely issue identification, resolution and implementation.Acts as primary liaison with publishing vendor(s) for all eCTD submissions. Oversees the compilation and collaboration with the eCTD vendors for all major and routine submissions (including but not limited to NDAs, IND, MAAs, amendments, supplements, promotional material (OPDP/APLB).Provides guidance and feedback to colleagues in terms of eCTD standards for electronic submissions (e.g., templates, style guides, hyperlinking, bookmarking, technology, Regulations, EDMS).Aids in the proper management, retention, and version control of all applicable submission documentation.Prepares and maintains SOPs, work instructions and checklists related to templates, electronic document management, electronic submission processes, submission document QC, and archiving.Manages and develops a competent and technically skilled submission operations organization (both FTEs and Contract).Experience and Qualifications:Bachelors degree or equivalent is required10 years of directly related experience,preferably in Regulatory Operations.Experience with an electronic document management system and/or workflows.Prior interaction with eCTD vendors and experience with outsourcing.Experience and knowledge in the preparation of global regulatory submissions (e.g., original IND/IND amendments, CTAs, NDA/BLA/MAA).Knowledge of eCTD content/format requirements and working knowledge of ICH and FDA guidance relevant to electronic regulatory submissionsProficient with Microsoft Office products and Adobe Acrobat.Experience and knowledge of eCTD and publishing tools (e.g., metadata, STF, ISIToolbox).Experience working in a team environment.Ability to manage people and projects.Ability to work both independently with direction and within project teams.Excellent verbal and written communication skills are essential.Proactive, strong organizational skills, the ability to prioritize workload and pay close attention to detail.Demonstrates personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments.Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.Critical Skills:Strategic problem-solving skills.Excellent organizational and multitasking abilities.A team player with leadership skills.Superior communication skills.Scientific curiosity strongly preferredDepartment: Clin Dev - Regulatory Location: Cambridge, MA

Keywords: Seres Therapeutics, Somerville , Director, Regulatory Operations, Executive , Somerville, Massachusetts

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