Barrington James

Compensation

Full Description

Note: The job is a remote job and is open to candidates in USA. Barrington James is partnering with a rapidly advancing biotechnology company pioneering transformative therapies in autoimmune diseases. The Vice President of Regulatory Affairs will define and drive the global regulatory strategy across the autoimmune disease pipeline, ensuring successful regulatory submissions and lifecycle management. Responsibilities • Lead the development and execution of comprehensive global regulatory strategies spanning early development to product registration and post-approval activities for autoimmune therapeutic candidates. • Serve as the primary regulatory liaison with global health authorities (FDA, EMA, PMDA, and others), leading critical agency interactions, briefing packages, and negotiation of regulatory pathways and approvals. • Oversee preparation, review, and submission of regulatory filings including INDs, CTAs, NDAs, BLAs, and MAAs, ensuring quality, compliance, and strategic alignment. • Provide expert guidance on regulatory policies relevant to autoimmune diseases, including accelerated approval pathways, orphan drug designation, biomarkers, and clinical endpoint definition. • Foster collaborative relationships within cross-functional teams to integrate regulatory considerations into clinical development programs and commercialization plans. • Build and mentor a high-caliber regulatory affairs team, promoting leadership development and operational excellence. Skills • 15+ years in regulatory affairs with progressive leadership scope, preferably within biotech or pharmaceutical companies focused on autoimmune or related therapeutic areas. • Proven success in global regulatory strategy development and regulatory submissions for complex biologics or novel therapies in autoimmune diseases. • Extensive experience navigating expedited regulatory pathways such as Fast Track, Breakthrough Therapy, Orphan Drug, and PRIME. • Strong record of productive engagements with health authorities and expertise managing regulatory risk in dynamic, high-growth environments. • Strategic visionary coupled with hands-on execution ability and excellent leadership presence. Education Requirements • Advanced scientific or professional degree (PhD, PharmD, MD, or MSc) highly preferred. Company Overview • Barrington James has a true global reach, with its international HQ in London-Gatwick, continental hubs in Singapore. It was founded in 2002, and is headquartered in New York, New York, USA, with a workforce of 201-500 employees. Its website is https://barringtonjames.com/.