Senior Regulatory Affairs Manager - Global Submissions

Ray Therapeutics, Inc.; Berkeley (CA); Hybrid; USD 170,000 - 185,000; Full time

Benefits offered by this job

Annual performance-based bonus

Annual equity awards

Comprehensive benefits package

Job summary

A biotechnology company focused on vision restoration therapies seeks a Senior Manager, Regulatory Affairs in Berkeley, CA. This role involves developing regulatory strategies for clinical-stage programs and managing interactions with agencies like the FDA. The ideal candidate will have at least 6 years of experience and a degree in life sciences. Competitive compensation includes a base salary between $170,000 and $185,000, alongside performance-based bonuses and equity awards.

Qualifications

• Minimum 6 years of regulatory affairs experience in the biotechnology industry.
• Direct experience supporting IND/CTA submissions and early-phase clinical development.
• Ability to travel up to 20%.

Responsibilities

• Develop and implement regulatory strategies for clinical-stage programs.
• Lead preparation, review, and submission of regulatory documents.
• Coordinate and author regulatory sections of key submissions.
• Manage interactions with regulatory agencies like FDA and EMA.
• Ensure compliance with applicable global regulatory requirements.

Skills

Regulatory strategy development

Cross-functional collaboration

Excellent writing skills

Project management

Knowledge of FDA regulations

Education

Bachelor’s degree in life sciences or related field

Advanced degree (MS, PhD, PharmD)

Job description

A biotechnology company focused on vision restoration therapies seeks a Senior Manager, Regulatory Affairs in Berkeley, CA. This role involves developing regulatory strategies for clinical-stage programs and managing interactions with agencies like the FDA. The ideal candidate will have at least 6 years of experience and a degree in life sciences. Competitive compensation includes a base salary between $170,000 and $185,000, alongside performance-based bonuses and equity awards.