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

Ascendis Pharma; Princeton (NJ); On-site; USD 150,000 - 200,000; Full time

Job summary

Ascendis Pharma seeks a Director, Global Regulatory Strategy and Policy Advisor to lead strategic initiatives and policy development. This role requires collaboration with senior leadership and cross-functional teams to drive regulatory strategies and ensure compliance with evolving regulations.

Benefits

401(k) plan with company match

Medical, dental, and vision plans

Company-offered Life and AD&D insurance

Short and long-term disability benefits

Pet Insurance and Legal Insurance

Employee Assistance Program

Professional Development

Flexible Spending Accounts

Paid leave benefits for new parents

Qualifications

• Minimum 12 years of experience in Regulatory Affairs leadership.
• Strong understanding of clinical development and regulatory strategies.

Responsibilities

• Develop and implement Global Regulatory Affairs plan across all products.
• Collaborate with various departments to advance regulatory policies.

Skills

Leadership

Project Management

Communication

Analytical Skills

Education

Advanced degree in Life Science

Job description

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

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

2 weeks ago Be among the first 25 applicants

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.

Position Summary

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 ideally be based in the Ascendis Pharma corporate offices in Palo Alto, CA or Princeton, NJ.

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 all 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 documentation and submissions
• Serve as a subject matter expert to advise staff on preparation for regulatory authority meetings, submissions and other critical regulatory documents
• Provide input to internal governance and advisory bodies as needed
• Actively collaborate with Senior Management and other cross-functional partners to provide portfolio or therapeutic level regulatory insight and broader drug development expertise
• Actively be up-to-date on the latest regulatory requirements and trends and contribute to the shaping of the regulatory science environment.
• Support regulatory intelligence and regulatory policy priorities by conducting comprehensive research on relevant issues, analyzing relevant data and collaborating with stakeholders to gather input and build consensus as needed
• Ensure exemplary behavior, leadership, ethics and transparency within the company, with Health Authorities and other external stakeholders
• Collaborate with Government Affairs, Regulatory Intelligence and other cross-functional partners to assess the impact of emerging legislative and other changes on product development and approvals and advise key stakeholders accordingly
• Represent the organization in relevant regulatory meetings, conferences, and public forums
• Stay informed about current events and emerging trends relevant to regulatory affairs

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.

Position Summary

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 ideally be based in the Ascendis Pharma corporate offices in Palo Alto, CA or Princeton, NJ.

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 all 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 documentation and submissions
• Serve as a subject matter expert to advise staff on preparation for regulatory authority meetings, submissions and other critical regulatory documents
• Provide input to internal governance and advisory bodies as needed
• Actively collaborate with Senior Management and other cross-functional partners to provide portfolio or therapeutic level regulatory insight and broader drug development expertise
• Actively be up-to-date on the latest regulatory requirements and trends and contribute to the shaping of the regulatory science environment.
• Support regulatory intelligence and regulatory policy priorities by conducting comprehensive research on relevant issues, analyzing relevant data and collaborating with stakeholders to gather input and build consensus as needed
• Ensure exemplary behavior, leadership, ethics and transparency within the company, with Health Authorities and other external stakeholders
• Collaborate with Government Affairs, Regulatory Intelligence and other cross-functional partners to assess the impact of emerging legislative and other changes on product development and approvals and advise key stakeholders accordingly
• Represent the organization in relevant regulatory meetings, conferences, and public forums
• Stay informed about current events and emerging trends relevant to regulatory affairs

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 12 years of documented professional experience at a Regulatory Affairs leadership position within the pharmaceutical or biotechnology industry or at a regulatory agency with focus on biologics, small molecules, synthetic peptides, or combination products.
• 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 agency
• 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, regulatory strategy, intelligence and policy, coupled with excellent scientific and business judgment
• Experience providingstrategic 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 regulatory environments

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.

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

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  IT Services and IT Consulting

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