Regulatory Affairs - Director

NexInfo Solutions, Inc.; San Francisco (CA); On-site; USD 220,000 - 300,000; Full time

Job summary

NexInfo Solutions, Inc. in the San Francisco Bay Area is seeking a Director, Regulatory Affairs to lead cross-functional development and regulatory submission activities for registrational oncology programs in the US.

The role focuses on crafting effective regulatory strategies and ensuring timely NDA filings in collaboration with Program Teams and Global Regulatory Leads. The candidate will manage the filing plan, lead Health Authority meetings, mitigate regulatory risks, and mentor junior

Qualifications

• Degree in life sciences, pharmacy, medicine, or related fields with extensive regulatory experience.
• Proven success leading US NDA filings (preparation, submission, approval).
• Experience with expedited pathways and Health Authority negotiations.

Responsibilities

• Lead cross-functional development and regulatory submission activities for registrational oncology programs in the US.
• Collaborate with Program Teams and Global Regulatory Leads to advance regulatory strategies for NDA filings.
• Develop filing plans under expedited pathways and manage NDA timelines and deliverables.
• Coordinate NDA filings and sub-team rosters for management endorsement.
• Lead NDA kickoff meetings per global filing plans and framework.
• Maintain integrated filing plans with regulatory timelines and critical path activities.
• Identify and mitigate risks to NDA timelines and regulatory outcomes; report to senior management.
• Drive modular NDA sub-teams across Clinical, Non-Clinical, and Product Label teams.
• Lead Health Authority meetings and responses; coordinate cross-functional preparation.
• Mentor and develop direct reports to ensure ongoing performance.

Skills

Regulatory affairs

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Project management

Communication

Education

Degree in life sciences, pharmacy, medicine, or related fields

Job description

Title: Director, Regulatory Affairs

Location: San Francisco Bay Area (Onsite)

Job Description

• 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.