Senior Manager Regulatory Affairs

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

Job/Role Title: Senior Manager, Regulatory Affairs

Reporting to: Chief Regulatory Officer

Ray Therapeutics mission is to restore vision to people with retinal degenerations. RayTx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate RTx-015 in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications.

Ray Therapeutics, Inc. is a clinical stage biotechnology company developing best-in-class vision restoration therapies for people with degenerative retinal diseases independent of genetic mutation. Reporting to the Chief Regulatory Officer, the Senior Manager, Regulatory Affairs will play a critical role in advancing the company’s clinical-stage pipeline by developing and executing regulatory strategies to support global development programs. This individual will serve as a key contributor to regulatory submissions, agency interactions, and cross-functional planning in a fast-paced environment.

Key Responsibilities include but are not limited to:

• Develop and implement regulatory strategies for clinical-stage programs in alignment with corporate objectives
• Lead preparation, review, and submission of regulatory documents, including INDs, CTAs, amendments, annual reports, and briefing packages
• Coordinate and author regulatory sections of key submissions (e.g., protocols, investigator brochures, IND modules)
• Serve as primary regulatory contact for assigned programs, collaborating closely with Clinical, CMC, Nonclinical, and Quality teams
• Manage interactions with regulatory agencies (e.g., FDA, EMA), including meeting requests, briefing documents, and responses to information requests
• Ensure compliance with applicable global regulatory requirements and guidelines
• Provide regulatory guidance to internal teams to support development plans and decision-making
• Track regulatory milestones and proactively identify risks and mitigation strategies
• Support development and improvement of regulatory processes, systems, and templates

Qualifications:

• Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred
• Minimum 6 years of regulatory affairs experience in the biotechnology industry
• Direct experience supporting IND/CTA submissions and early-phase clinical development
• Strong knowledge of FDA regulations and ICH guidelines; familiarity with ex-US regulatory frameworks is a plus
• Proven ability to work cross-functionally in a small, dynamic organization
• Excellent writing, communication, and project management skills
• Ability to travel up to 20%
• Ability to work from our Berkeley, CA office a minimum of 2 days per week

Please note that you must reside within assigned territory and note territory when applying

At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

Compensation Range and Benefits:

• For this role, the anticipated base salary range: $170,000 to $185,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
• Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.

All employment is decided on the basis of qualifications, merit, and business need

Search Firm Representatives Please Read Carefully

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