Senior Regulatory Affairs Lead Global Submissions Strategy

Regulatory Toolkit; South San Francisco (CA); On-site; USD 180,000 - 195,000; Full time

Job summary

Marea Therapeutics, a clinical-stage biotechnology company based in South San Francisco, seeks a Senior Manager, Regulatory Affairs to lead regulatory support for assigned programs worldwide.

Reporting to the Director, Regulatory Affairs, you will develop regulatory strategies, coordinate submissions, and ensure compliance with FDA/EMA regulations across regions, with on-site work three days per week.

Qualifications

• Bachelor’s degree is required, preferably in a scientific field; advanced degree is a plus.
• 8+ years in drug development with 5+ years in regulatory affairs in biotech/pharma; cardiometabolic/cardiovascular or endocrinology is a plus
• Strong working knowledge of international regulatory requirements and GXP
• Experience with eCTD and electronic submissions
• Experience with international regulatory submissions and processes is a strong plus
• Ability to work effectively across teams, functions and with outside partners
• Excellent oral and written communication skills; strong organizational skills and attention to detail

Responsibilities

• Formulate regulatory strategies with supervisor oversight.
• Collaborate with cross-functional teams and external partners to develop regulatory strategies and identify risks.
• Manage preparation and timely submission of regulatory documents and filings.
• Review global regulatory submissions for consistency and quality across regions.
• Prepare responses to queries from regulatory authorities.
• Maintain up-to-date knowledge of FDA/EMA regulations and ICH guidelines.
• Ensure conformance to commitments with regulatory agencies (IND/CTA).
• Provide regulatory advice to other functions.
• Participate in regulatory due diligence activities.

Skills

Regulatory affairs experience

Cross-functional collaboration

Communication skills

Attention to detail

Education

Bachelor’s degree (scientific field)

Advanced degree preferred

Tools

eCTD knowledge

Clinical submissions systems

Job description

Marea Therapeutics, a clinical-stage biotechnology company based in South San Francisco, seeks a Senior Manager, Regulatory Affairs to lead regulatory support for assigned programs worldwide.

Reporting to the Director, Regulatory Affairs, you will develop regulatory strategies, coordinate submissions, and ensure compliance with FDA/EMA regulations across regions, with on-site work three days per week.