• Regulatory Labeling Manager

    Actalent (South San Francisco, CA)


    Job Title: Director, Regulatory Advertising, Promotion & Labeling (Part Time)

    Job Description

    The Regulatory Labeling Manager serves as a vital member of the MLR team, providing strategic, science-driven regulatory guidance to cross-functional teams. The role involves offering insights on promotional strategy, claim development, labeling alignment, and risk management. As a key regulatory thought partner, you will enable compliant communication of complex clinical and scientific data across Commercial and Medical leadership.

    Responsibilities

    + Serve as the Regulatory representative on the MLR team.

    + Independently review and approve promotional materials to ensure compliance with FDA regulations, product labeling, guidance documents, and internal policies.

    + Assess the impact of labeling changes on promotional strategy and ensure timely, compliant updates across all materials.

    + Support promotion of products in development, including accelerated approval and post-marketing commitment considerations.

    + Serve as primary liaison with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising & Promotional Labeling Branch (APLB).

    + Lead regulatory strategy and execution for OPDP submissions, including advisory comments, time-of-first-use submissions, Form 2253 filings, etc.

    + Monitor FDA enforcement trends, regulatory guidance, and biotech industry best practices; translate insights into internal guidance and training.

    + Partner closely with Medical Affairs, Clinical Development, Labeling, Legal, and Commercial teams to ensure consistent, accurate, and compliant messaging across channels.

    + Provide strategic regulatory labeling guidance to cross-functional teams.

    + Oversee the creation, revision, and maintenance of product labeling, including Core Data sheet, Prescribing Information (USPI), Medication Guides, Patient Package Inserts, and container labeling.

    + Ensure consistency and alignment between labeling content, clinical data, risk management activities, and promotional messaging.

    Essential Skills

    + 8–10+ years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry.

    + 5+ years of direct experience in Regulatory Advertising & Promotion.

    + Demonstrated experience supporting product launches and lifecycle experience with FDA advertising and promotion regulations.

    + Knowledge of FDA evidence standards for promotional claims, including interpretation of clinical trial data and scientific literature.

    + Excellent written and verbal communication skills and strong regulatory judgment.

    + Proficiency with regulatory and document management systems and Microsoft Office tools.

     

    Additional Skills & Qualifications

     

    + Bachelor’s degree in a scientific, healthcare-related, business, or legal discipline.

    + Advanced scientific degree (MS, MD, PharmD, PhD) preferred.

    + Experience participating in Label Working Groups and supporting U.S. and global labeling strategies.

     

    Work Environment

     

    This is a remote, part-time position, offering flexibility and the ability to work from home.

     

    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 $90.00 - $150.00/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 Jan 28, 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 [email protected] (%[email protected]) for other accommodation options.