Job Title: Senior Manager/Director of Regulatory Affairs

Fully remote

Must Work West Coast Hours

Job Description

This position provides strategic regulatory leadership for assigned oncology programs, with accountability for global regulatory strategy, execution, and outcomes across various stages of development. The role involves defining and maintaining global regulatory strategies for IND/CTA maintenance, clinical development, and product registration in the U.S., EU, and other key regions, including Asia-Pacific.

Responsibilities

Serve as the primary regulatory spokesperson in formal interactions with the FDA, including leading meeting preparation and conduct.Plan, prepare, review, and submit high-quality regulatory dossiers, such as INDs, CTAs, NDAs/BLAs, MAAs, and respond to regulatory agency inquiries.Partner with cross-functional stakeholders to ensure clear, consistent, and strategically aligned messaging across global regulatory submissions.Proactively identify, assess, and communicate regulatory risks, proposing mitigation strategies and alternative pathways as appropriate.Ensure regulatory activities comply with applicable regulations and internal quality standards.Maintain clear and timely communication with Senior management regarding regulatory strategy, milestones, and critical issues.Contribute to regulatory intelligence and policy interpretation, advising internal teams on evolving global regulatory requirements and their impact on development programs.Support inspection activities as needed.

Essential Skills

Demonstrated experience in leading global regulatory strategies and submissions, including INDs, CTAs, and preferably marketing applications (NDA/BLA/MAA).Proven ability to serve as the lead regulatory representative in FDA interactions.Strong strategic thinking, problem-solving, and decision-making skills in complex, fast-paced environments.Excellent written and verbal communication skills, capable of clearly conveying complex regulatory concepts to diverse audiences.Experience with expedited development and approval pathways such as Fast Track, Breakthrough Therapy, and PRIME.

Additional Skills & Qualifications

Bachelor's degree in a life sciences discipline; advanced degree (MS, PhD, PharmD) strongly preferred.8+ years of progressive experience in Regulatory Affairs within drug development, including significant oncology experience.

Work Environment

The role is remote, operating primarily in the Pacific Standard Time (PST) zone.

Job 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 20, 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.