Senior Manager / Director, Regulatory Affairs (Oncology)

12‑Month Contract | Remote (PST Hours ONLY)

We are seeking an experienced Regulatory Affairs leader to support oncology development programs across U.S. and global markets. This fully remote contract role leads global regulatory strategy from early development through registration.

Key ResponsibilitiesLead global regulatory strategy for assigned oncology programsOversee IND/CTA maintenance, clinical development, and registration pathwaysServe as the lead regulatory representative in FDA interactionsPrepare and review INDs, CTAs, NDAs/BLAs, MAAs, and agency responsesPartner cross‑functionally to ensure aligned regulatory submissionsIdentify regulatory risks and propose mitigation strategiesEnsure compliance with global regulations and internal standardsRequirementsBachelor’s in Life Sciences; advanced degree preferred8+ years Regulatory Affairs experience in drug development (oncology required)Experience with global regulatory submissions and FDA meetingsStrong communication, strategic thinking, and problem‑solving skillsExperience with expedited pathways (Fast Track, Breakthrough, PRIME) preferredJob Type & Location

This is a Contract position based out of South San Francisco, CA.

Pay and Benefits

The pay range for this position is $95.00 - $140.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Feb 12, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.