Director of Regulatory Writing (Biotechnology)

  • Location

    California

  • Sector:

  • Job type:

    Temporary

  • Salary:

    Negotiable

  • Contact:

    Maisie Hockings

  • Contact email:

    m.hockings@ioassociates.com

  • Job ref:

    BBBH165763_1760451420

  • Duration:

    12 Months

  • Startdate:

    ASAP

Director of Regulatory Writing (Biotech)

Contract Duration: Up to 12 months
Rate: Up to $140 per hour (DOE)

iO Associates is partnering with a clinical-stage biopharmaceutical company advancing innovative therapies for serious infectious diseases and oncology. The business is driven by a mission to harness the power of the immune system to improve patient outcomes. With a strong pipeline spanning late preclinical to clinical-stage assets, they are now seeking a Regulatory Writing Director (Contract) to support key global submissions and clinical documentation activities.

The Opportunity

As the Regulatory Writing Director, you'll play a pivotal role in preparing high-quality, compliant documents that support regulatory submissions to global health authorities (FDA, EMA, and others). You'll work cross-functionally with clinical, biostatistics, regulatory affairs, and safety teams to ensure scientific accuracy, clarity, and consistency across all programs.

This role reports into the SVP of Regulatory Affairs and offers the opportunity to contribute to a high-impact development pipeline.

Key Responsibilities

  • Author and edit a range of regulatory documents including clinical protocols, Investigator's Brochures (IBs), Clinical Study Reports (CSRs), briefing documents, IND/NDA/MAA submission modules, and summaries of efficacy and safety.

  • Ensure all documents comply with ICH and other applicable regulatory guidelines (e.g., ICH E3, ICH M4).

  • Translate complex clinical and scientific data into clear, concise, and accurate regulatory language.

  • Collaborate closely with cross-functional leads to ensure alignment and consistency across programs.

  • Plan and manage writing deliverables, timelines, and review cycles for multiple concurrent projects.

About You

  • Bachelor's degree in a scientific or medical discipline (advanced degree preferred).

  • 10+ years of experience in regulatory or medical writing within biotechnology or pharmaceuticals.

  • Strong familiarity with eCTD structure and ICH guidelines.

  • Experience authoring key regulatory documents such as CSRs, IBs, DSURs, protocols, and clinical modules.

  • Proven involvement in marketing applications (INDs, NDAs, BLAs, MAAs, or equivalent).

  • Ability to manage multiple priorities and communicate effectively across disciplines.

Why Join

You'll join a purpose-driven, science-led organization that values collaboration, integrity, and innovation. This is an excellent opportunity to contribute to life-changing programs while working within a flexible and supportive environment.