Associate Director - Regulatory Labeling

February 27

Apply Now

Receive Emails with Similar Jobs

Scholar Rock

WebsiteLinkedInAll Job Openings

Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Our most advanced investigational product candidate, apitegromab (SRK-015), a

51 - 200 employees

Founded 2016

💰 $205M Post-IPO Equity on 2022-06

📋 Description

• Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. • As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins, the clinical-stage company is focused on advancing innovative treatments. • The Associate Director, Regulatory Labeling is responsible for overseeing the development, implementation and maintenance of global product labeling content and strategy. • This role will also coordinate and run the Labeling Working Group (LWG) and ensure compliance with labeling regulations and guidance.

🎯 Requirements

• Bachelor’s degree or advanced scientific degree (MSc, PhD, PharmD) preferred • 5+ years of direct experience in regulatory affairs global labeling • Experience that demonstrates ability to create development labeling processes and documents (initial CCDS). • Ability to research and understand complex scientific and regulatory information and distil important aspects for impact to labeling. • Strong project management skills to plan, prioritize, lead, and execute individual work, and teamwork related to regulatory labeling in a systematic and efficient manner. • In-depth and practical knowledge of labeling requirements globally (USPI and SmPC required), including development and life-cycle management of local PIs and PILs.