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Ascendis Pharma · 2 weeks ago

Senior Manager, Regulatory Project Manager - Job ID: 1820

Princeton, NJ

Full-time

Hybrid

Senior Level, Lead/Staff

$160K/yr - $175K/yr

8+ years exp

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with a focus on Endocrinology Rare Disease and Oncology. The Regulatory Project Manager will provide project management leadership to key global regulatory submissions across the Ascendis pipeline, contributing to the vision, strategy, and infrastructure of Global Regulatory Affairs.

BiotechnologyClinical TrialsHealth Care

Responsibilities

Collaborate with Global Regulatory Affairs Leadership in establishing and managing timelines for key project milestones, adhering to processes and documentation, and communicating with cross-functional teams or key stakeholders within and across regions to ensure the delivery of business objectives

Participate in Regulatory filing teams, providing project management expertise in the end-to-end planning, coordination, and execution of assigned Regulatory submissions project deliverables

Monitor submission deliverables as required to support investigational (IND/CTA) and marketing applications (BLA/NDS/MAA), and global clinical trials as required

Work with key stakeholders for major submissions, identifying risks, opportunities and mitigation strategies, ensuring successful and on-time project execution

Provide project management support to regulatory agency interactions and the preparations for the interaction

Strive for efficiency by ensuring consistent approaches and development of best practices

Qualification

Regulatory AffairsDrug Development ProcessProject ManagementRegulatory FrameworkECTD Submission RequirementsMicrosoft Office SuiteInterpersonal SkillsCommunication SkillsOrganizational SkillsTime Management

Required

Degree in life science or equivalent. MS, MBA and/or PMP desired

A minimum of 8 years of experience: 5 years in drug, biologic and/or combination products in Regulatory Affairs and 3 years of experience performing directly relevant Regulatory Project Management activities within the pharmaceutical and/or biotechnology industries

Familiarity with Regulatory framework and understanding of the overall drug development process, early and late stage (IND, CTA, BLA, NDA, MAA)

Experience in participating in Regulatory filing teams with ability to look across multiple programs for submission related conflicts or resourcing constraints

Ability to identify and document all regulatory project deliverables from each functional area for global regulatory submissions

Maintain detailed timelines for global regulatory strategies for assigned therapeutic areas in US, EU, UK, CAN, and ROW, and ensure planning and coordination of activities via the Submission Project Teams

Thorough working knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g., FDA, EMA, ICH, etc.) and global eCTD submission requirements (e.g., US, EU, UK, CA)

Strong interpersonal, communication, organizational/planning, and time-management skills

Ability to present complex information in an easy-to-understand format to all levels of stakeholders

Detail-oriented with ability and desire to work in a fast paced, team oriented, small company environment, with the ability to manage simultaneous priorities and challenging deadlines

Advance proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Project), MS Project, and MS Teams

Prior experience with an EDMS required

Ability to travel up to 20% of the time domestically and internationally