Global CMC Regulatory Lead - Small Molecule Innovation

Scorpion Therapeutics; Indiana (PA); Hybrid; USD 149,000 - 257,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Scorpion Therapeutics in Indianapolis, IN seeks a senior Regulatory CMC professional to lead global submissions and lifecycle strategies for synthetic molecules; you will guide cross-functional teams and shape regulatory pathways.

You will author CMC filings, interact with Health Authorities, and support ongoing product development, with relocation help, limited travel, and a flexible approach to remote work.

Qualifications

• B.S. in a science, engineering, or STEM field (advanced degree preferred); e.g., Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar.
• 10+ years of Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic molecules.
• Authoring CMC submissions; involvement in clinical trial applications/marketing authorization processes and responses.
• Knowledge of major market procedures/regulations/practices; awareness of evolving initiatives.
• Experience with synthetic molecule drug substance/drug product development, commercialization, or manufacturing.
• Experience planning for/participating in Health Authority meetings.
• Risk assessment/management in highly regulated environments; strong communication and leadership/influence skills.

Responsibilities

• Deep technical knowledge of small molecule CMC drug development and manufacturing sciences across modalities and platforms (drug substance, drug product, analytical sciences).
• Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining/maintaining product registrations.
• Develop and implement regulatory strategies and platform approaches based on new guidance, evolving expectations, and regulatory precedent.
• Provide regulatory guidance to CMC development teams for development and product lifecycle planning.
• Lead preparation, critical review, and approval of CMC documents for global regulatory submissions (clinical trial applications, marketing applications, variations/supplements, and health authority information requests).
• Proactively lead critical review of molecule-specific CMC development and lifecycle strategies.
• Provide timely, clear regulatory advice to support informed project decisions.
• Make CMC regulatory strategy decisions impacting submissions across geographies/networks.

Skills

CMC Regulation

Regulatory Strategy

Cross-functional Leadership

Regulatory Submissions

Health Authority Meetings

Education

BS in Science/Engineering

Job description

Scorpion Therapeutics in Indianapolis, IN seeks a senior Regulatory CMC professional to lead global submissions and lifecycle strategies for synthetic molecules; you will guide cross-functional teams and shape regulatory pathways.

You will author CMC filings, interact with Health Authorities, and support ongoing product development, with relocation help, limited travel, and a flexible approach to remote work.