Senior Director, Regulatory Affairs - Job ID: SDRA 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 experience expected from applicants, as well as additional skills and qualifications needed for this job are listed below. The Senior Director, Regulatory Affairs will serve as the therapeutic area head for assigned products and lead the US RA Strategy team. This dual 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. It is essential to clearly state in the Position Summary that this role combines both responsibilities, emphasizing its dual nature. 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 with stakeholders such as the FDA, EMA, and other key regulatory bodies. The candidate must be adept at formulating and driving strategy, with strong leadership and hands-on regulatory experience. The ideal candidate will have a proven ability to partner effectively across 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. Demonstrating outstanding leadership, scientific rigor, and an understanding of the business aspects of drug development are crucial. We seek a highly motivated individual who thrives in collaborative environments and is passionate about developing medicines for devastating diseases. This position reports to the VP, Regulatory Affairs, and is ideally based in Palo Alto, CA, or Princeton, NJ. Key Responsibilities Collaborate with Clinical Development, Pharmacovigilance, Biometrics, Core Teams, Product Management, and Leadership to develop and implement US and global regulatory strategies. Oversee the development and refinement of regulatory policies, procedures, and SOPs. Work with cross-functional teams on launch strategies, lifecycle planning, especially focusing on North and South American markets. Provide regulatory assessments of product opportunities and threats. Monitor the competitive landscape to maintain expertise in therapeutic areas and emerging therapies. Update status reports and communicate risks and achievements to teams and senior management. Minimum Requirements Advanced degree (Master's or PhD) in Life Sciences with experience leading BLA/NDA filings. At least 12 years of regulatory leadership experience within the pharma/biotech industry, focusing on biologics, small molecules, or peptides. Deep understanding of clinical development and experience in presenting clinical data to FDA. Preferred experience with drug-device combination products. Extensive regulatory experience including IND/CTA, NDA/BLA/MAA, lifecycle management, and labeling. Proven ability to collaborate across functions and geographies. Ability to travel up to 30-40 days annually. Experience working directly with FDA and international agencies, especially in North and South America. Leadership experience in mentoring and managing regulatory teams. Excellent communication and presentation skills.

#J-18808-Ljbffr