Senior Regulatory Affairs Manager, Global Submissions

Initial Therapeutics, Inc.; South San Francisco (CA); On-site; USD 180,000 - 195,000; Full time

Job summary

Marea Therapeutics, a clinical-stage biotechnology company in South San Francisco, seeks a Senior Manager, Regulatory Affairs to lead regulatory support for assigned programs and ensure robust planning and tactical execution for US and international development strategies. The role is on-site in South San Francisco.

The candidate will oversee regulatory document submissions, interact with authorities, and guide teams through IND/CTA processes, ICH guidelines, and global regulatory expectations.

Qualifications

• Bachelor’s degree required; advanced degree a plus.
• 8+ years drug development with 5+ years in regulatory affairs preferred.
• Strong knowledge of international regulatory requirements and GXP.
• Experience with FDA/EMA and IND/CTA processes.
• Excellent written and oral communication; cross-functional collaboration.

Responsibilities

• Develop regulatory strategies with governance from supervision.
• Coordinate cross-functional teams to identify regulatory risks.
• Oversee preparation and timely submission of regulatory documents.
• Review global submissions for consistency and quality.
• Coordinate responses to regulatory authority queries.
• Maintain up-to-date knowledge of FDA/EMA regulations and ICH guidelines.
• Ensure conformance to regulatory commitments for programs.
• Provide regulatory guidance to other functions.
• Support regulatory due diligence activities.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory intelligence

Regulatory advisory

Communication skills

Education

Bachelor's degree

Advanced degree

Tools

eCTD

Job description

Marea Therapeutics, a clinical-stage biotechnology company in South San Francisco, seeks a Senior Manager, Regulatory Affairs to lead regulatory support for assigned programs and ensure robust planning and tactical execution for US and international development strategies. The role is on-site in South San Francisco.

The candidate will oversee regulatory document submissions, interact with authorities, and guide teams through IND/CTA processes, ICH guidelines, and global regulatory expectations.