Senior Manager, Regulatory Project Manager position at Ascendis Pharma, responsible for leading project management for key global regulatory submissions across the Ascendis pipeline, collaborating with cross-functional teams, and managing timelines and milestones.
Requirements
- Degree in life science or equivalent.
- A minimum of 8 years of experience 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.
- 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.
Benefits
- 401(k) plan with company match
- Medical, dental, and vision plans
- Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
- Company-provided short and long-term disability benefits
- Unique offerings of Pet Insurance and Legal Insurance
- Employee Assistance Program
- Employee Discounts
- Professional Development
- Health Saving Account (HSA)
- Flexible Spending Accounts
- Various incentive compensation plans
- Accident, Critical Illness, and Hospital Indemnity Insurance
- Mental Health resources
- Paid leave benefits for new parents
