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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. In this role, you will be responsible for providing advice on global regulatory strategies to product development teams and driving key policy initiatives. This position demands a high level of expertise in product development, policy analysis, stakeholder engagement, and the ability to synthesize complex information into actionable recommendations. Whether you are contributing to public sector reforms, advising on regulatory frameworks, or advising on strategies to advance our product development plans, your insights and guidance will play a pivotal role in shaping outcomes that matter.

The Director, Global Regulatory Strategy and Policy Advisor, will work closely with the executive team to formulate strategies, enhance performance, implement relevant policies, and provide key insights that enable the organization to operate collaboratively and proactively. This role involves engaging closely with internal peers and external stakeholders such as regulatory and other government agencies.

The ideal candidate will have a proven ability to partner effectively with multiple functions, including Clinical Development, Research, Product Development, Medical Affairs, Government Affairs, Commercial and Quality. Strong interpersonal skills are essential, as this individual will serve as a trusted voice within the company. The candidate must demonstrate outstanding leadership and project management skills, rigorous scientific intellect, and an understanding of the business aspects of drug development.

At a personal level, the company is seeking a highly motivated individual who thrives on being challenged and working in highly collaborative environments to contribute to their cutting-edge science.

This highly visible position requires a high level of energy, focus, and a passion and sense of urgency for developing important new medicines for devastating diseases. This candidate will report to the Chief Regulatory & Safety Officer and may work remotely.

Key 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.

Requirements

+ Advanced degree (Master’s, PharmD, JD, PhD or equivalent) in Life Science with experience working as an RA project lead of marketing authorization filings, or as a reviewer, compliance and/or policy expert at a health authority or other government agencies.

+ Minimum 10 years of documented professional experience at a Regulatory Affairs leadership position within the pharmaceutical or biotechnology industry with focus on biologics, small molecules, or synthetic peptides

+ Strong understanding of clinical development and how to present clinical data to regulatory agencies as well as a proven track record in developing regulatory affairs strategies

+ Extensive regulatory experience including IND/CTA, NDA/BLA/MAA, lifecycle management, labelling, and developing regulatory strategies

+ Proven ability to collaborate effectively with multiple functions, including Research, Development, Clinical, Commercial, and Quality across locations and cultures

+ Ability to travel domestically and internationally for business purposes as needed

+ Broad experience in Regulatory Affairs, working directly with a regulatory agencies

+ Experience with biologics, CMC, Toxicology, regulatory incentives, such as Orphan Drug Designation, breakthrough designation, fast track designation, priority review vouchers, etc.

+ Excellent written and verbal communication skills, as well as interpersonal and presentation skills

+ Strong knowledge of drug development and regulatory policy, coupled with excellent scientific and business judgment.

+ Experience providing strategic regulatory advice for the global development of products through all stages of development including pre-approval and marketed assets.

+ Successful track record of registering and overseeing regulatory strategies for assets.

+ Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion. Ability to work under pressure and meet tight deadlines.

+ Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management.

+ Proven track record practicing sound judgment as it relates to risk assessment

+ Highly conversant and knowledgeable of new and emerging regulations and guidances.

+ Experience in governmental or non-governmental policy analysis and development.

+ Strong understanding of legislative and regulatory processes.

+ Demonstrated ability to work collaboratively with diverse stakeholders.

+ Experience in project management and strategic planning.

+ Strong analytical skills and the ability to interpret complex data.

+ Ability to work independently and manage multiple tasks effectively.

+ Strong organizational skills and attention to detail.

+ Commitment to ethical practices and public service.

+ Flexibility and adaptability to changing policy environments.

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