Regulatory Lead

Scorpion Therapeutics; United States; Remote; USD 170,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Regulatory Affairs leader to oversee global filings and compliance for a late-stage ophthalmic biologic product with FDA approval and European marketing authorization. You will lead end-to-end submissions (BLA, MAA, INDs, CTAs) and post-approval activities, coordinating with FDA, EMA, and MHRA to shape regulatory strategy for biologics and combination devices.

You will manage cross-functional teams and vendors, ensuring labeling and promotional materials

Qualifications

• Bachelor's in life sciences required.
• 8+ years in regulatory affairs within biopharma.
• Experience with biologics and combination products.
• Experience with FDA and European authorities.
• Willingness to work US/EU hours.

Responsibilities

• Lead end-to-end preparation and submission of BLA, MAA, INDs, CTAs, and post-approval lifecycle activities.
• Serve as primary interface with FDA, EMA, MHRA; manage interactions with health authorities.
• Develop regulatory strategies for biologics and combination devices.
• Lead cross-functional teams and vendors to ensure regulatory compliance for labeling and promotional materials.

Skills

Regulatory affairs leadership

FDA/EMA engagement

CMC documentation

Global filings

Cross-functional leadership

Education

Bachelor's in life sciences

Job description

Role:

Senior Regulatory Affairs leader overseeing global filings and compliance for a late-stage ophthalmic biologic product with FDA approval and European marketing authorization.

Responsibilities:

• manage end-to-end preparation and submission of BLA, MAA, INDs, CTAs, and post-approval lifecycle activities; serve as primary interface with FDA, EMA, MHRA; develop regulatory strategies for biologics and combination devices; lead interactions with health authorities and manage cross-functional teams and vendors; ensure regulatory compliance for labeling and promotional materials.

Requirements:

• Bachelor's in life sciences; 8+ years in regulatory affairs within biopharma, with experience in biologics, combination products, and global filings; proven track record with FDA and European authorities; strong CMC and manufacturing documentation expertise; willingness to work US/EU hours.

Preferred:

• ophthalmology/retina experience; experience supporting product launches or international expansion; background managing consultants and cross-company teams; mentoring experience.

High-value specifics:

• biologics, combination devices, FDA/EMA/UK MHRA engagement, global regulatory strategy, product lifecycle management, remote work (US-based, East Coast preferred).