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 Direct message the job poster from SciPro 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.

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