Associate Director, Regulatory Project Manager - Job ID: 1163

Ascendis Pharma

Ascendis Pharma

Legal, Operations
Palo Alto, CA, USA
Posted on Wednesday, July 19, 2023

The Regulatory Project Manager will be an integral part of Regulatory Affairs, providing project management leadership to key global regulatory submissions across the Ascendis pipeline.

As a part of the Regulatory Affairs team, you will be responsible for contributing to the vision, strategy, and infrastructure of Ascendis Global Regulatory Affairs. This role of the will be based in Palo Alto and will report directly to the Director of Regulatory Affairs Operations.

Key Responsibilities

  • Collaborate with 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 on 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.
  • Degree in life science or equivalent. MS, MBA and/or PMP desired.
  • A minimum of 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. Orphan drug experience preferred.
  • Familiarity with Regulatory framework and understanding of the overall drug development process, early and late-stage (IND, CTA, BLA, NDA, MAA).
  • Experience in participating on 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. Experience with Veeva Vault Regulatory systems preferred.
  • Ability to travel up to 20% of the time domestically and internationally.
    • Salary Range: $155K-175K/year
  • Medical insurance
  • Vision insurance
  • Dental insurance
  • 401(k)
  • Paid maternity leave
  • Paid paternity leave
  • Commuter benefits
  • Disability insurance