Head Regulatory Affairs, Early Development Pipeline

CT19; Massachusetts; Remote; USD 130,000 - 180,000; Full time

Job summary

A leading biotech organization is seeking a Head of Regulatory Affairs to join their team in the US. This role involves implementing regulatory strategies for early phase studies, ensuring compliance with regulatory filings, and leading a dedicated team. Ideal candidates have experience in rare diseases and a strong understanding of the biopharma landscape.

Qualifications

• Experience with INDs and CTAs for phase I trials.
• Global filing experience in US and Europe.
• Previous pharma or biotech experience preferred.

Responsibilities

• Implement regulatory strategies for studies up to phase I.
• Lead early phase regulatory team.
• Participate in early phase disease area committee.

Skills

Regulatory strategy for early phase compounds

Knowledge of biopharma regulatory landscape

Adaptability to fast-paced environment

Job description

Head Regulatory Affairs, Early Development Pipeline

Position: Head of Regulatory Affairs, Early Development Pipeline

Specialization: Rare Disease

Experience Required: Early Phase Filings

Location: Remote in the US, candidate must reside in the east coast time zone or be willing to relocate

Travel: Initial travel to HQ in Europe for a few months, then approximately once a quarter or as needed for business-critical requirements

About the Company

We collaborate with a European biotech organization developing novel therapeutics for rare diseases. They have achieved FDA approvals and are expanding into new markets. The portfolio includes preclinical to approved products, with ongoing exploration of new indications. We seek a Head of Regulatory Affairs, Early Development to support rapid growth in the early pipeline, reporting to the Global Head of Regulatory Affairs.

About the Role

This is an exciting opportunity to join the global regulatory leadership team. You will be responsible for implementing regulatory strategies for studies up to the end of phase I/first-in-human/ proof of concept. You will lead the early phase regulatory team and participate in the early phase disease area committee, focusing on FIH & proof of concept study design and conduct.

Candidate Requirements

• Experience with regulatory strategy for early phase compounds, including phase I trials in healthy volunteers, with successful filings such as INDs and CTAs
• Global regulatory filing experience in the US & Europe; additional markets like Canada are a plus
• Pharma or biotech experience; rare disease, unmet medical need, or innovative medicine background is advantageous
• Strong knowledge of early-stage drug development and the biopharma regulatory landscape
• Willingness to work operationally and hands-on when necessary
• Ability to adapt to a fast-paced, demanding biotech environment and strategic pipeline changes

Please submit an updated CV for consideration.

Additional Information

• Seniority level: Director
• Employment type: Full-time
• Job function: Quality Assurance, Legal, and Others
• Industries: Pharmaceutical Manufacturing and Biotechnology Research

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