Advance global regulatory efforts with Satellos as an Associate Director in Regulatory Affairs. This remote role focuses on crucial submissions, compliance, and strategy for DMD and FSHD pipelines.

The Associate Director will report directly to the Chief Development Officer and Head of Regulatory Affairs. You will contribute to the success of our lead DMD program through regulatory submissions and compliance tracking. Key duties include preparing detailed regulatory dossiers and liaising with Health Authorities while following global guidelines and harmonization initiatives.

Key Responsibilities:



• Prepare and submit regulatory dossiers including INDs and CTAs • Provide input on clinical development plans and protocols • Review promotional and clinical materials for compliance • Maintain regulatory intelligence on guidance and competitors • Lead regulatory interactions with Health Authorities

Requirements: • Bachelor’s Degree in relevant scientific field, advanced degree preferred • 7 to 10 years in the pharmaceutical or biotech industry • Experience with global regulatory pathways • Proven leadership in major global submissions • Hands-on eCTD assembly experience

Elevate regulatory strategies and ensure compliance in a agile environment at Satellos. #J-18808-Ljbffr

📌 Regulatory Affairs Associate Director Remote (Markham)
🏢 Satellos
📍 Markham