Remote Regulatory Affairs CMC Director

Regulatory Jobs; United States; Remote; USD 190,000 - 285,000; Full time

Benefits offered by this job

Hybrid work/remote flexibility

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Pre-tax commuter benefits

Health benefits

Job summary

Eidos Therapeutics, Inc. seeks an Associate Director/Director of Regulatory Affairs CMC to independently manage regulatory processes, prepare documentation for global submissions, and lead CMC strategy across BridgeBio subsidiaries.

The role emphasizes cross-functional collaboration and regulatory leadership. The candidate should have deep knowledge of global CMC requirements, strong communication skills, and the ability to drive timelines and robust regulatory responses in a fast-paced

Qualifications

• A bachelor’s degree in life sciences is required.
• Minimum of 7 years in regulatory affairs/CMC or related field in pharma.
• Excellent communication and attention to detail.
• Ability to manage projects independently with limited direction.
• Strong computer skills (MS Office, document management like Veeva).
• Self-starter with initiative and independent work style.
• Strong interpersonal, active listening and influencing skills.
• Ability to leverage AI tools to support complex tasks and decision making.

Responsibilities

• Develop global CMC regulatory strategies with managers and SMEs to meet objectives for the Eidos program.
• Collaborate with cross-functional teams to prepare CMC sections of regulatory dossiers (ROW).
• Plan and coordinate preparation of CMC sections and manage author/review/approval workflows.
• Provide RA CMC support for Health Authority interactions and draft/briefing book coordination.
• Address Health Authority questions and regulatory strategy input as needed.
• Maintain current knowledge of global regulations, guidance, and standards for drug development and registration.
• Other duties as assigned.

Skills

Regulatory affairs

CMC

Project management

Communication

AI tools

Interpersonal skills

Education

Bachelor's degree in life sciences

Tools

Veeva

Microsoft Office

Job description

Eidos Therapeutics, Inc. seeks an Associate Director/Director of Regulatory Affairs CMC to independently manage regulatory processes, prepare documentation for global submissions, and lead CMC strategy across BridgeBio subsidiaries.

The role emphasizes cross-functional collaboration and regulatory leadership. The candidate should have deep knowledge of global CMC requirements, strong communication skills, and the ability to drive timelines and robust regulatory responses in a fast-paced