Director, Global Regulatory Strategy and Policy Advisor - Job ID: 1652

Ascendis Pharma A/S; Princeton (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Join a dynamic biopharmaceutical company as a Director of Regulatory Strategy and Policy Advisor. This innovative firm is at the forefront of developing groundbreaking therapies in Endocrinology, Rare Disease, and Oncology. You'll work closely with senior leadership and cross-functional teams to shape regulatory strategies and drive policy initiatives that align with the company's mission. This role demands a blend of scientific rigor, leadership, and project management skills. If you're passionate about making a difference in the lives of patients and thrive in collaborative environments, this is the opportunity for you!

Benefits

401(k) with company match

Health plans

Insurance options

Employee assistance

Professional development

Qualifications

• Expertise in global regulatory strategies and product development.
• Strong analytical skills for policy analysis and recommendations.

Responsibilities

• Develop and implement the Global Regulatory Affairs plan.
• Collaborate with cross-functional teams to enhance product strategies.

Skills

Regulatory Strategy

Policy Analysis

Stakeholder Engagement

Project Management

Drug Development

Interpersonal Skills

Education

Master's Degree in Life Sciences

PhD in Regulatory Science

Job description

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.

Ascendis Pharma is looking to hire an experienced Director, Regulatory Strategy and Policy Advisor to join our team. This is an exciting opportunity to join a rapidly growing innovative company.

The Director, Global Regulatory Strategy and Policy Advisor will be at the forefront of our strategic and policy initiatives, working closely with senior leadership and key cross-functional stakeholders to analyze, develop, and implement strategies and drive policies that align with our mission and objectives. Responsibilities include providing advice on global regulatory strategies to product development teams and driving key policy initiatives. The role demands expertise in product development, policy analysis, stakeholder engagement, and the ability to synthesize complex information into actionable recommendations.

This position involves working closely with the executive team to formulate strategies, enhance performance, and provide insights that enable proactive collaboration. Engagement with internal peers and external stakeholders such as regulatory and government agencies is essential.

The ideal candidate will effectively partner with Clinical Development, Research, Product Development, Medical Affairs, Government Affairs, Commercial, and Quality teams. Strong interpersonal, leadership, project management skills, scientific rigor, and understanding of drug development business aspects are required.

We seek a highly motivated individual who thrives in collaborative environments and is passionate about developing important new medicines for devastating diseases. The role reports to the Chief Regulatory & Safety Officer and may be remote.

Key Responsibilities

1. Collaborate with and advise Clinical Development, Pharmacovigilance, Biometrics, Core Team Members, Product Management, Commercial, Medical Affairs, and Leadership to develop and implement the Global Regulatory Affairs plan, including launch strategies and lifecycle management.
2. Advance regulatory and government policy initiatives impacting product development and commercialization in partnership with Government Affairs and Commercial teams.
3. Contribute to regulatory due diligence assessments of product opportunities.
4. Monitor the competitive environment to identify threats and opportunities for our products.
5. Review strategic regulatory submissions and advise on regulatory authority meetings, submission strategies, and critical documents.
6. Provide insights to internal governance and advisory bodies on strategic and operational issues.
7. Collaborate with senior management and cross-functional teams to provide regulatory insight and drug development expertise.
8. Stay current on regulatory requirements and trends, contributing to the shaping of the regulatory science environment.
9. Support regulatory intelligence and policy priorities based on internal expertise.
10. Ensure exemplary behavior, leadership, ethics, and transparency with health authorities and external stakeholders.
11. Research policy issues, analyze data, and develop policy proposals and recommendations for governmental and non-governmental organizations.
12. Engage stakeholders to gather input and build consensus on regulatory policy initiatives.
13. Monitor legislative developments and update on relevant policy changes.
14. Prepare reports, briefing notes, and presentations on regulatory policy matters.
15. Advise senior management on policy options and implications.
16. Evaluate existing policies and recommend adjustments.
17. Participate in public consultations and community outreach for regulatory policy initiatives.
18. Coordinate with interdisciplinary teams for policy coherence and representation in regulatory meetings, conferences, and forums.
19. Stay informed on current events and emerging trends relevant to policy areas.

We also offer a comprehensive benefits package including 401(k) with company match, health plans, insurance options, employee assistance, professional development, and more to support our team members.