• Head of Regulatory Affairs, Oncology - Job ID: 1404 Palo Alto
  • Ascendis Pharma in Palo Alto, CA, United States
  • jobs
  • 1 month ago

jobs description

We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we’re advancing programs in Endocrinology Rare Disease, and Oncology.

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 are a dynamic workplace for employees to grow and develop their skills.

This position will be responsible for developing and implementing global regulatory strategies in Oncology. Ensures compliance with all applicable policies and global regulatory requirements in a timely manner. Provides expertise in translating regulatory requirements into practical, workable plans for project teams with international participants. Mentors and supervises 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 overarching 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; 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

· Must be willing to provide hands-on, study level help as needed in addition to oversee direct reports

· 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

· Work is performed under direction of the Head of Clinical Development, Oncology

· Contributes to internal regulatory policies and procedures to achieve best practices and work processes

· BS/BA Degree in a Scientific Discipline required. Advanced Degree preferred

· Minimum of 15 years in the biopharmaceutical industry with at least 10 years overall regulatory experience (with at least 6 of those years in Oncology)

· Prior Senior Management experience representing Regulatory Affairs on cross-functional teams is desirable.

· Must have hands-on experience in successfully leading cross-functional teams for submissions of regulatory dossiers including CTAs, IMPDs, INDs; experience with BLAs/NDAs/MAAs in solid tumors are required; accelerated approval experience a plus

· 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

· Ability to travel up to 10-20% of the time domestically and internationally

Estimated compensation: $320-350K/year
• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Commuter benefits
• Disability insurance
Palo Alto CA USA


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