Associate Director/Director/ Sr. Director, Regulatory CMC

Scorpion Therapeutics; Raleigh (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a Lead Regulatory CMC to shape strategy and oversee global regulatory submissions for biologics, primarily monoclonal antibodies, from development through post-approval lifecycle.

You will work with Quality, Manufacturing, and external CMOs to ensure compliance with FDA/EMA/ICH regulations and drive regulatory submissions across the product lifecycle. Strong leadership and biopharma expertise are essential for success in this role.

Qualifications

• 5-10 years in Regulatory CMC within biopharma.
• Strong expertise in biologics, analytical methods, process development, manufacturing, and quality control.
• Experience with biologics, combination products, or cell therapies preferred.
• Knowledge of device/regulatory requirements (21 CFR Part 4, ISO 13485).
• BS in a scientific/engineering discipline; MS, PhD, or PharmD preferred.
• Demonstrated success in preparing submissions and managing cross-functional teams.

Responsibilities

• Coordinate and oversee global CMC regulatory submissions (INDs, BLAs, DMFs, amendments).
• Author and review CMC sections; respond to agency queries; ensure compliance with evolving regulations (FDA, EMA, ICH).
• Collaborate with internal Quality, Manufacturing, and external partners such as CMOs and consultants.
• Provide regulatory guidance across product lifecycle, including post-approval changes.

Skills

Regulatory CMC

Biologics (MAbs)

Cross-functional leadership

Regulatory submissions

Analytical methods

Education

BS in science/engineering

MS/PhD/PharmD preferred

Job description

Role

Lead Regulatory CMC strategy and operations for biologics, primarily monoclonal antibodies, supporting clinical development through post-approval lifecycle management.

Responsibilities

• coordinate and oversee global CMC regulatory submissions (INDs, BLAs, DMFs, amendments), author and review CMC sections, respond to agency queries, and ensure compliance with evolving international regulations (FDA, EMA, ICH).
• Collaborate with internal Quality, Manufacturing, and external partners such as CMOs and consultants.
• Provide regulatory guidance across product lifecycle, including post-approval changes.

Requirements

• 5-10 years in Regulatory CMC within biopharma, with strong expertise in biologics (MABS), analytical methods, process development, manufacturing, and quality control.
• Experience with biologics, combination products, or cell therapies preferred.
• Knowledge of device/regulatory requirements (21 CFR Part 4, ISO 13485).
• BS in a scientific/engineering discipline; MS, PhD, or PharmD preferred.
• Demonstrated success in preparing submissions and managing cross-functional teams.

High-value

• biologics, monoclonal antibodies, Regulatory CMC, global filings, lifecycle management, device/combination product experience.

Work setup

not specified.