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TRexBio · 1 day ago

Senior Director, Regulatory Affairs

South San Francisco, CA

Full-time

Hybrid

Director/Executive

$220K/yr - $290K/yr

10+ years exp

TRexBio is a clinical stage biotechnology company focused on developing revolutionary therapeutics for inflammatory diseases. The Senior Director, Regulatory Affairs will lead the regulatory strategy for the company's pipeline, working closely with clinical teams and engaging with regulatory authorities to ensure successful execution of regulatory deliverables.

BioinformaticsBiopharmaBiotechnology

Responsibilities

Serve as a key member of cross functional clinical and pre-clinical teams to develop and implement the US and global regulatory strategy across products

Lead Regulatory deliverables including INDs, CTAs, and other submissions

Oversee development of regulatory policies and procedures and SOPs

Engage with regulatory authorities as appropriate for product development

Monitor the competitive environment to sustain expertise in therapeutic area treatment management and new therapies, competitive products and features

Qualification

Regulatory AffairsINDsCTAsLeadership experienceClinical developmentBiologics expertiseCollaboration skillsCommunicationPresentation skills

Required

Advanced degree (Master's or PhD) in Life Science with experience working as a regulatory project lead for INDs, CTAs, and BLAs

Minimum 10 years of documented professional experience in Regulatory Affairs, including in leadership positions within the biopharmaceutical industry with focus on biologics

Strong understanding of clinical development and how to present clinical data to FDA as well a proven track record in developing regulatory affairs strategies

Extensive regulatory experience including IND/CTA, NDA/BLA/MAA, lifecycle management, labelling, and developing regulatory strategies

Proven ability to collaborate effectively with multiple functional leaders, including Research, Development, Clinical, product Strategy, Manufacturing, and Quality across locations and cultures

Ability to travel domestically and internationally

Broad experience in Regulatory Affairs, working directly with FDA and international agencies

Experience with immunology and development of medicines for immune mediated diseases, biologics, CMC, Toxicology, Orphan Drugs development, breakthrough and fast track regulatory processes

Strong leadership experience, including mentoring staff and managing regulatory teams across locations

Excellent writing, communication, and presentation skills

Benefits

Discretionary Bonus

Company

TRexBio

TRexBio is a clinical-stage biotechnology company discovering and developing immunoregulatory medicines based on tissue Treg biology by leveraging cutting-edge computational biology tools, a focus on human tissue, and deep immunobiology expertise.

Founded in 2018

South San Francisco, California, USA

11-50 employees