Regulatory Affairs - Director

Title: Director, Regulatory Affairs

Location: San Francisco Bay Area (Onsite)

Job Description:

Reports into Regulatory Affairs, Global Filing & Registration:

• High-Impact position to lead cross-functional development & regulatory submission activities for registrational oncology programs in the US.
• Collaborate closely with Program Teams and Global Regulatory Leads to advance effective & consistent regulatory strategies to enable successful filing of approval of New Drug Applications.
• Develop strategic filing plans under expedited regulatory pathways, programs and developing Health Authority initiatives.
• Coordinate NDA Filing and Sub-team rosters for management endorsement.
• Lead cross-functional NDA kickoff according to global filing plans and framework.
• Maintain & track an integrated filing plan including regulatory timelines, modular NDA deliverables, critical path activities, in concert with Regulatory Program Management.
• Identify, respond to, and proactively mitigate risks to NDA timelines or regulatory outcomes and report progress to senior management.
• Drive and/or support modular NDA Sub-teams (e.g., across Clinical, Non-Clinical, Product Label, etc.) to ensure consistent communication, timely data delivery, and issue resolution.
• Lead relevant Health Authority meetings, interactions and query responses and coordinate cross functional team preparation & involvement.
• Motivate, mentor and develop direct reports to ensure development and performance.

Required Skills, Experience and Education:

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.
• Proven success in executing US NDAs (preparation, submission & approval)
• Experience filing applications under expedited filing pathways and programs to enable fastest possible regulatory approval.
• Demonstrated ability to lead Health Authority interactions and negotiations.
• In-depth knowledge of CTD structure and management of dossier components.
• Direct experience in oncology drug development including oversight of large, global Phase 3 registrational studies.
• Flexibility to support business needs of dynamic registrational programs.
• Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.
• Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.

Preferred Skills:

• An advanced degree is desirable.