Sr. Director RA Early Development Lead

Proclinical Staffing; Boston (MA); Remote; USD 245,000 - 265,000; Full time

Job summary

A leading biotech firm seeks a Senior Director of Regulatory Affairs to drive global early development strategy. This pivotal role supports first-in-human programs in an innovative, science-driven environment offering a competitive compensation, ideal for someone passionate about impactful science.

Qualifications

• 15+ years in regulatory affairs within global biotech/pharma.
• Significant hands-on experience in designing global regulatory strategies.
• Known for integrity, clarity, and leading through ambiguity.

Responsibilities

• Own global regulatory strategy for early-stage programs.
• Lead a cross-functional regulatory team dedicated to early clinical development.
• Interact with global health authorities and regulatory forums.

Skills

Regulatory Affairs

Leadership

Scientific Fluency

Strategic Planning

Collaboration

Education

PhD or PharmD

Job description

Sr. Director RA Early Development Lead - Permanent - Remote within US

Looking to escape your long commute to work? Unlock your next remote working position with this exciting role in Regulatory Affairs!

About the Opportunity:

A well-capitalized, innovation-driven biotech at the forefront of immunology and rare disease is seeking a senior regulatory affairs leader to shape and scale global early development strategy. This is a rare opportunity to drive first-in-human (FIH) programs from concept through to clinical execution in an agile, science-first environment backed by strong leadership and pipeline momentum.
You'll play a pivotal role in bridging scientific discovery and clinical translation-leading global regulatory direction through a period of meaningful expansion and early-stage pipeline acceleration.

Skills & Requirements:

• 15+ years in regulatory affairs within global biotech/pharma, including senior leadership roles
• Significant expertise in early-stage development, with hands-on experience in designing global regulatory strategies for FIH programs
• Deep scientific fluency; PhD or PharmD preferred
• Track record in advancing biologics or innovative therapies into the clinic
• Collaborative, process-minded, and experienced in scaling regulatory operations
• Known for integrity, clarity, and an ability to lead through ambiguity
• Passionate about building something meaningful from the ground up

The Senior Director's responsibilities will be:

• Own global regulatory strategy for early-stage programs, from pre-IND through proof of concept
• Lead a cross-functional regulatory team dedicated to early clinical development
• Partner with research, clinical, and portfolio stakeholders to align development strategy with long-term regulatory success
• Advise on optimal trial design and regulatory pathways for orphan, rare, and pediatric indications
• Champion the implementation of new internal regulatory systems and operating models
• Serve as a key voice in shaping early development policy across multiple therapeutic areas
• Engage with global health authorities and regulatory forums to represent the organization externally

Why This Role:
You'll be joining a company on the cusp of its next chapter-expanding its early pipeline while investing in bold science and global reach. You won't just manage process; you'll create it. Ideal for someone who thrives on innovation, clarity of mission, and long-term impact.
If you're ready to shape the future of early development strategy at a biotech that moves differently, let's talk!

Compensation:

• $245,000 to $265,000 per annum.

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at [e-mail]

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

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