This range is provided by SciPro. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$230,000.00/yr - $250,000.00/yr

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Overview

SciPro is partnered with a late-stage biotech that's searching for a Director, Regulatory Affairs Strategy to join their team full-time. This role will lead the development and execution of global regulatory strategies and play a key role in leading regulatory submissions. The team is currently getting ready for a BLA, following a Phase 3 data readout in the first half of 2026. The company is at a pivotal stage, backed by a strong financial runway and highly engaged investors who view the company as one of the most exciting next-generation biotechs to watch. With Phase 3 data expected in 2026, investor enthusiasm is high, and if approved, this therapy has the potential to become a standard addition to routine bloodwork and clinical care. Their differentiated approach offers a patient-friendly dosing profile and a promising safety edge, positioning them to potentially reshape the standard of care in a large and underserved therapeutic area. This is a hybrid position with 2 days onsite.

Responsibilities

• Partner with senior leaders and cross-functional stakeholders to shape and execute regulatory plans that guide clinical development programs.
• Drive communication with international regulatory agencies (such as FDA, EMA, MHRA, PMDA) by drafting briefing packages, preparing for key interactions, and leading discussions with authorities.
• Oversee the planning and delivery of high-quality regulatory filings across global regions, ensuring accuracy and timely completion.
• Contribute to submissions including BLAs, MAAs, INDs and their amendments, annual updates, designation requests (orphan, breakthrough, PRIME, fast track), responses to agency questions, and pediatric development proposals.
• Serve as the regulatory voice within project and clinical study teams, advising on the application of relevant guidelines and standards.
• Establish and refine internal regulatory processes and frameworks suitable for the organization’s stage of development.

Requirements

• 10+ years of pharmaceutical industry experience, including direct regulatory affairs experience with increasing responsibility.
• Demonstrated experience authoring and overseeing the compilation of regulatory dossiers for global.
• Experience preparing global regulatory submissions for drug or biologic (protein therapeutics) products (INDs, NDA/BLAs, MAAs).

Seniority level

• Director

Employment type

• Full-time

Job function

• Science

Industries

• Pharmaceutical Manufacturing and Biotechnology Research

Note: This description retains the core job information and removes extraneous sections not essential to the role.