Senior Scientist, Regulatory Affairs-Chemistry, Manufacturing and Control

Merck; Cambridge (MA); Sur place; USD 140 000 - 200 000; Plein temps

Résumé du poste

Scorpion Therapeutics in Cambridge, MA is seeking a Senior Scientist (R3) in Regulatory CMC Biologics to serve as project lead, developing and executing global regulatory strategies for biologics. Hybrid work with some travel is offered in the US.

Responsibilities include managing CMC documentation for INDs, BLAs, and variations; ensuring regulatory compliance; and assessing risks across the product lifecycle while collaborating with regulatory and development teams.

Qualifications

• 5+ years in Regulatory CMC with biologics experience preferred.
• BS in science or engineering; advanced degree preferred.
• Experience managing CMC documentation for INDs/BLAs and variations.

Responsabilités

• Lead development and execution of global regulatory strategies for biologics.
• Manage CMC documentation and regulatory submissions (INDs, BLAs, variations).
• Assess regulatory risks across product lifecycle and ensure compliance.

Connaissances

Regulatory affairs management

Documentation

Compliance

Communication with health authorities

eCTD proficiency

Formation

Bachelor's degree in science or engineering

Description du poste

Senior Scientist (R3) in Regulatory CMC Biologics

serving as project lead to develop and execute global regulatory strategies for biologics.

Responsibilities

• Managing CMC documentation (INDs, BLAs, variations)


• Ensuring compliance


• Assessing regulatory risks across product lifecycle stages

Requirements

• BS in a science or engineering field (advanced degree preferred)


• 5+ years in Regulatory CMC, with biologics experience strongly preferred

Core Skills

• Regulatory affairs management


• Documentation


• Compliance


• Communication with health authorities


• Proficiency in electronic submissions (eCTD)

High-value biopharma specifics include biologics, vaccine development, regulatory submissions, and post-approval lifecycle management.

Collaboration involves cross-functional teams within regulatory and development units.

Work setup is hybrid, based in the US, with some travel expected.