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Ocugen Inc

Clinical Trial Manager

Malvern, PA · On-site

The CTM plays a critical role in driving studies aligned with Ocugen's development and business strategies. Responsibilities * Lead the planning, execution, and delivery of clinical studies in ...

Ocugen

Executive Assistant

Malvern, PA · On-site

... Ocugen. This position will report to the Senior Executive Business Manager. Duties and Responsibilities * Administrative support to include heavy calendar management, domestic and international ...

Ocugen Inc

Executive Assistant

Malvern, PA · On-site

Job Purpose The Executive Assistant will provide support to the CMO, as well as backup support to the CEO with diverse administrative duties and create a positive first impression of Ocugen. This ...

OCUGEN OPCO INC

Executive Assistant

Malvern, PA · On-site

Job Purpose The Executive Assistant will provide support to the CMO, as well as backup support to the CEO with diverse administrative duties and create a positive first impression of Ocugen. This ...

OCUGEN OPCO INC

Clinical Trial Manager

Malvern, PA

The CTM plays a critical role in driving studies aligned with Ocugen's development and business strategies. Responsibilities * Lead the planning, execution, and delivery of clinical studies in ...

Ocugen Inc

Senior Clinical Data Manager

Malvern, PA · On-site

Position Summary The Senior Clinical Data Manager plays a pivotal role within Ocugen's clinical data management team. This individual will lead data management efforts, oversee quality data ...

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How much do ocugen jobs pay per hour?

As of Aug 25, 2026, the average hourly pay for ocugen in the United States is $26.34, according to ZipRecruiter salary data. Most workers in this role earn between $15.14 and $30.77 per hour, depending on experience, location, and employer.

What is Ocugen?

Ocugen is a biopharmaceutical company focused on developing gene therapies to cure blindness diseases and other medical conditions. The company specializes in innovative treatments for rare and underserved eye disorders, including inherited retinal diseases and age-related macular degeneration. Ocugen also works on vaccine development and has been involved in partnerships to bring COVID-19 vaccines to market. Their mission is to improve the quality of life for patients by offering breakthrough solutions in ophthalmology and regenerative medicine.

What are the key skills and qualifications needed to thrive as a Clinical Research Associate at Ocugen, and why are they important?

To thrive as a Clinical Research Associate at Ocugen, you typically need a degree in life sciences, experience in clinical trials, and knowledge of regulatory guidelines like GCP. Familiarity with electronic data capture (EDC) systems, trial management software, and relevant certifications (such as SOCRA or ACRP) is often required. Strong attention to detail, organizational skills, and effective communication help ensure studies run smoothly and data integrity is maintained. These skills are vital for supporting successful clinical trials, maintaining compliance, and advancing drug development in a regulated environment.

What are some typical challenges faced by professionals working at Ocugen in the biotechnology sector?

Professionals at Ocugen often navigate a fast-paced and highly regulated environment, where balancing innovation with strict compliance standards is essential. Working on breakthrough therapies can involve tight deadlines, cross-functional collaboration, and adapting to evolving clinical or regulatory requirements. Since teams are multidisciplinary, effective communication and flexibility are key to addressing unforeseen scientific or technical obstacles. Employees also need to stay current with the latest research and industry trends to contribute effectively to the company's mission.

What is the difference between Ocugen vs Bioinformatics Technician?

AspectOcugenBioinformatics Technician
Required CredentialsBiotech or related degree, possibly with regulatory knowledgeBachelor's in bioinformatics, biology, or related field; some roles may require coding skills
Work EnvironmentResearch labs, biotech companies, pharmaceutical settingsLaboratories, research institutions, biotech firms, often involving data analysis
Industry UsageBiotech, gene therapy, vaccine developmentGenomics, data analysis, research in biotech and healthcare

Ocugen focuses on vaccine and gene therapy development within biotech and pharmaceutical industries, often involving laboratory research and clinical trials. Bioinformatics Technicians primarily analyze biological data, supporting research and development in biotech and healthcare sectors. While both roles require a background in biology or related fields, Ocugen roles emphasize laboratory work and product development, whereas Bioinformatics Technicians focus on data analysis and computational tasks.

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Ocugen jobs near you
Infographic showing various Ocugen job openings in the United States as of August 2026, with employment types broken down into 100% Full Time. Highlights an 92% Physical, and 8% Remote job distribution, with an average salary of $54,791 per year, or $26.3 per hour.

AD/ Director, Clinical Regulatory Affairs Gene Therapy

Malvern, PA • On-site

Ocugen Inc
Biotechnology Research and Development • 51 - 200 employees
Learn more about Ocugen Incexternal

$147K - $194K/yr

Full-time

Re-posted 4 days ago

Job description

Position Summary
The Associate Director, Regulatory Affairs - Gene Therapy will play a highly visible role in advancing Ocugen's clinical-stage gene therapy programs through critical phases of development and global regulatory engagement. This individual will help shape regulatory strategy for innovative therapies intended to address serious unmet medical needs and will work closely with executive leadership, Clinical Development, Clinical Operations, Medical Affairs, and Regulatory teams to support accelerated pathways toward potential approval and commercialization.
This is a unique opportunity to contribute meaningfully to multiple gene therapy programs at a pivotal stage of growth, with direct exposure to FDA and global health authority interactions, cross-functional development strategy, and late-stage regulatory planning. The ideal candidate brings strong clinical regulatory experience within biotechnology or pharmaceuticals, preferably in gene therapy, biologics, or other advanced therapeutics.
Responsibilities
Clinical Regulatory Strategy & Execution
  • Support development and execution of global regulatory strategy for Ocugen's gene therapy programs from early clinical development through potential registration.
  • Provide strategic regulatory guidance on clinical development plans, study design, endpoints, protocol development, and lifecycle planning.
  • Lead or support preparation of regulatory submissions including INDs, CTA/IMPDs, BLAs/MAAs, briefing packages, responses to agency questions, and other health authority communications.
  • Partner closely with Clinical Development, Clinical Operations, Biometrics, Medical Writing, Safety, and Regulatory Operations to ensure aligned execution of regulatory milestones.
  • Support and participate in interactions with FDA and global regulatory agencies including Type A/B/C meetings, INTERACT meetings, scientific advice meetings, and pre-BLA discussions.
  • Contribute to regulatory strategy for expedited and innovative approval pathways including RMAT, Fast Track, Orphan Drug, PRIME, and related designations.
  • Collaborate with technical and quality functions to ensure regulatory submissions are complete, aligned, and delivered according to program timelines.
  • Support integrated regulatory planning across clinical, nonclinical, and product development activities.

Regulatory Leadership & Cross-Functional Collaboration
  • Serve as a key regulatory representative on cross-functional program teams supporting clinical advancement and corporate objectives.
  • Help identify regulatory risks, develop mitigation strategies, and support proactive agency engagement plans.
  • Contribute to regulatory intelligence activities and interpretation of evolving global guidance related to gene therapy and advanced biologics.
  • Support development of scalable regulatory processes, tools, and best practices within a fast-paced biotechnology environment.
  • Collaborate closely with senior leadership on program priorities, timelines, and strategic development opportunities.

  • Bachelor's or Master's degree in life sciences required; advanced degree (MS, PhD, PharmD) preferred.
  • 8+ years of experience in Regulatory Affairs within biotechnology or pharmaceuticals, with direct experience in gene therapy, cell therapy, or biologics.
  • Direct experience supporting clinical-stage biotechnology programs, preferably within gene therapy, biologics, cell therapy, or advanced therapeutics.
  • Experience participating in FDA and/or global health authority interactions.
  • Hands-on experience supporting INDs, CTAs/IMPDs, BLA/MAA submissions, and lifecycle management activities.
  • Strong understanding of expedited regulatory pathways and evolving regulatory frameworks for advanced therapies.
  • Experience working in fast-paced, highly collaborative biotech environments with significant cross-functional visibility.

Working Conditions
This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.
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About Ocugen

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

Malvern, PA, US

Year founded

2013

Social media

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