Director, Global Regulatory Strategy and Policy Advisor

Summary

Join Ascendis Pharma as the Director, Global Regulatory Strategy and Policy Advisor, a leading role in shaping strategic and policy initiatives. Collaborate closely with senior leadership and cross-functional stakeholders to develop and implement strategies aligned with company objectives. Provide expert advice on global regulatory strategies to product development teams and drive key policy initiatives. This position requires extensive expertise in product development, policy analysis, stakeholder engagement, and synthesizing complex information. You will work closely with the executive team and external stakeholders, including regulatory agencies. This highly visible role demands strong leadership, project management, and scientific intellect, and reports to the Chief Regulatory & Safety Officer with remote work options.

Requirements

• Proven ability to partner effectively with multiple functions, including Clinical Development, Research, Product Development, Medical Affairs, Government Affairs, Commercial and Quality
• Strong interpersonal skills
• Outstanding leadership and project management skills
• Rigorous scientific intellect
• Understanding of the business aspects of drug development
• Highly motivated individual who thrives on being challenged and working in highly collaborative environments
• High level of energy, focus, and a passion and sense of urgency for developing important new medicines for devastating diseases

Responsibilities

• Collaborate with and advise Clinical Development, Pharmacovigilance, Biometrics, Core Team Members, Product Management, Commercial, Medical Affairs, and Leadership team to develop and implement the Global Regulatory Affairs plan across products, design and implement launch strategies and tactics, and plan the life cycle management of our products globally
• Collaborate with Government Affairs and Commercial to advance important regulatory and other government policies that impact product development and commercialization
• Contribute to regulatory due diligence assessments of product opportunities
• Monitor the competitive environment to maintain awareness of threats to and opportunities for our products
• Contribute to the review of strategic regulatory submissions
• Advise staff in preparation for regulatory authority meetings and provide input to submission strategy and other critical regulatory documents
• Provide input to internal Governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise
• Actively collaborate with Senior Management and cross-functional partners to provide portfolio or therapeutic level regulatory insight and broader drug development expertise
• Actively be up to date on latest regulatory requirements and trends, and contribute to the shaping of the regulatory science environment
• Support regulatory intelligence and policy priorities based on Ascendis’ internal knowledge and expertise
• Ensure exemplary behavior, leadership, ethics and transparency within the company, with Health Authorities and other external stakeholders
• Conduct comprehensive research on policy issues and analyze relevant data
• Develop policy proposals and recommendations for governmental and non-governmental organizations
• Collaborate with stakeholders to gather input and build consensus on regulatory policy initiatives
• Monitor legislative developments and provide updates on relevant regulatory policy changes
• Prepare detailed reports, briefing notes, and presentations on regulatory policy matters
• Advise senior management and other decision-makers and stakeholders on policy options and implications
• Evaluate the impact of existing policies and suggest necessary adjustments
• Engage in public consultations and community outreach to gather diverse perspectives on regulatory policy initiatives
• Coordinate with interdisciplinary teams to ensure regulatory policy coherence and alignment
• Represent the organization in relevant regulatory meetings, conferences, and public forums
• Stay informed about current events and emerging trends relevant to policy areas

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