Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.
Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.
Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.
The Regulatory Project Manager will be an integral part of Global Regulatory Affairs, providing project management leadership to key global regulatory submissions across the Ascendis pipeline.
As a part of the Global Regulatory Affairs team, you will be responsible for contributing to the vision, strategy, and infrastructure of Ascendis Global Regulatory Affairs. This role can be based in either our Palo Alto, CA or Princeton, New Jersey office, and will report directly to the Head of Global Regulatory Operations.
Key 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.
Requirements
- 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. 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 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. Experience with Veeva Vault Regulatory systems preferred.
- Ability to travel up to 20% of the time domestically and internationally.
The estimated salary range for this position is $160K-175K/year. Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.
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
A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.
