Associate Director, 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.

The Associate Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Ensures timely preparation of organized and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans for project teams with international participants. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory process-related topics. Requires ability to work strategically, both independently and in a team environment. The position will be based in Palo Alto, CA.

Key Responsibilities

• Responsible for strategic and operational regulatory input for cross functional (CMC, non-clinical and clinical) areas in collaboration with other project team members and regulatory colleagues.

• Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations.
• Provides regulatory information and guidance for product development and planning throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure compliance and product expansion.
• Acts as the company representative with regulatory authorities
• Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs.
• Excellent organizational skills and ability to work on and/or oversee a number of projects with tight timelines.
• Maintains up-to-date knowledge of highly complex regulatory requirements and communicates changes in regulatory information to project teams.
• Schedules and arranges own activities and those of direct reports.
• Work is performed under direction of a Senior Regulatory Affairs professional.
• Contribute to internal regulatory policies and procedures to achieve best practices and work processes.

Requirements

• BS/BA Degree in a Scientific Discipline, Advanced Degree required.
• Minimum of 8 years overall regulatory experience, and preferably including experience managing investigational and marketed products.
• Prior experience representing Regulatory Affairs on cross-functional teams is desirable.
• Must be capable of effectively leading teams in preparation of submissions.
• Experience working on international teams desirable.
• Experience working on international submission desirable.
• Must have an extensive knowledge of regulatory requirements, including ICH and regional requirements, and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business.
• Must be capable of critically reviewing complex technical documents and influencing colleagues across functions.
• Experience with drug-device combination products preferred.
• Experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with marketing applications is a plus.
• Ability to travel up to 10-20% of the time domestically and internationally.
• Salary Range - $190-215K/year

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

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Commuter benefits
• Disability insurance