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.The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned products and lead the US RA Strategy team. This role involves managing regulatory submissions and providing strategic leadership to ensure the successful design and execution of non-clinical and clinical trials as well as Life Cycle Management Strategies.
The Sr. Director 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 externally stakeholders such as the FDA, EMA, and other key regulatory bodies. The candidate must not only be adept at formulating and driving strategy, but also be tactically oriented, an exceptional leader with strong people management skills and playing a hands-on role in regulatory.The ideal candidate will have a proven ability to partner effectively with multiple functions, including Clinical development, Research, Product Development, Medical 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 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 position requires a high level of energy, focus, and a passion and sense of urgency for developing important new medicines for devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in the Ascendis Pharma corporate offices in Palo Alto, CA or Princeton, NJ.TAH for assigned product and Head of US RA. Phrase it as you deem fit but make it clear that this is a dual role, somewhere within the Position Summary section of the JD.
Key Responsibilities
- Collaborate with Clinical Development, Pharmacovigilance, Biometrics, Core Team Members, Product Management, and Leadership teams to develop and implement the US and global regulatory affairs plan across products
- Oversee development and refinement of regulatory policies and procedures and SOPs
- Work closely with Commercial, Clinical Development, Medical Affairs, Pharmacovigilance, Biometrics, Core Team Members, Product Management, and Leadership teams in designing and implementing launch strategies and tactics, and life cycle planning with primary focus on the North and South American markets
- Provide regulatory assessments of product opportunities and threats
- Monitor the competitive environment to sustain expertise in therapeutic area treatment management and new therapies, competitive products and features
- Updating status reports and progress summaries to share risks and achievements with Submission team, sub-teams, and senior management
Requirements
- Advanced degree (Master’s or PhD) in Life Science with experience working as a RA project lead of BLA and/or NDA filings
- Minimum 12 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 FDA as well a proven track record in developing regulatory affairs strategies
- Preferred experience with a drug device combination products
- 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 up to 30-40 days per year domestically and internationally
- Broad experience in Regulatory Affairs, working directly with FDA and international agencies with focus on North and South America
- Experience with biologics, CMC, Toxicology, Orphan Drugs development, breakthrough and fast track regulatory processes
- Strong leadership experience, including mentoring staff and managing regulatory teams across locations
- Excellent writing, communication, and presentation skills
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
