Job Description

Senior Associate, Regulatory Affairs

Location: Thousand Oaks, CA; Remote/Hybrid

Department: Regulatory Affairs

Reports To: Regulatory Affairs Director

Employment Type: Full-time

About Us:

Our mission at Capsida is to develop a new class of targeted gene therapies for patients with debilitating and life-threatening diseases, with an early focus on the CNS. Our unique technology allows us to generate capsids that are optimized to target specific tissues and cells, with the goal of enhancing efficacy and safety. Our current pipeline comprises three internal programs as well as several partnered programs.

Position Overview:

We are seeking a highly motivated Regulatory Affairs Senior Associate to join our team. The ideal candidate will have a background working with CBER-regulated products specifically within the gene therapy space. As a Regulatory Affairs Senior Associate, you can expect to work with other members of the regulatory team as well as cross-functionally with CMC, nonclinical, and clinical teams to support regulatory strategies and submissions related to the development of AAV gene therapy products. You will help the organization ensure compliance with global regulations, and contribute to the successful advancement of our innovative therapies starting from early-phase preclinical development and into the clinic.

Key Responsibilities:

• Regulatory Submissions: Prepare and manage regulatory submissions including Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), Clinical and CMC amendments, Special Designation Requests (Fast Track, RMAT, etc.) and Health Authority Meeting Packages.
• Regulatory Strategy: Collaborate with cross-functional teams (R&D, clinical, quality, and manufacturing) to develop and implement regulatory strategies that ensure successful product development and approval. Provide regulatory guidance throughout the lifecycle of gene therapy programs.
• Regulatory Compliance: Stay up-to-date on global regulatory requirements, guidelines, and standards for gene therapy. Ensure compliance with FDA, EMA, ICH, and other relevant regulatory authorities. Assist with audits, inspections, and assessments related to early-phase submission activities.
• Documentation and Reporting: Review and assist in the preparation of regulatory documents and ensure that they meet the required regulatory standards. Track and report the status of regulatory submissions and communicate any issues or changes to the project teams.
• Cross-Functional Collaboration: Work closely with R&D, Clinical Operations, Quality Assurance, Manufacturing, and other departments to support the development of gene therapy products. Provide regulatory expertise to ensure that programs are aligned with regulatory expectations.
• Regulatory Intelligence: Monitor changes in the regulatory landscape for gene therapies, keeping the team informed of new developments, opportunities, and potential risks. Advise on strategies for navigating emerging regulatory requirements.

Qualifications:

• Education: Bachelor’s degree in Life Sciences, Regulatory Affairs, Pharmacy, or a related field.
• Experience: At least 3-5 years of experience in regulatory affairs or a related field within the biotech industry. Experience in gene therapy is preferred. Understanding of FDA, EMA, Health Canada, and other global regulatory agencies and relevant regulatory interactions is essential.
• Knowledge: In-depth understanding of regulatory requirements and guidelines for biologics. Understanding of gene therapy guidelines is preferred. Familiarity with FDA and EMA guidance documents and experience preparing IND, CTA, and IMPD submissions is preferred.
• Skills: Excellent written and verbal communication skills, with the ability to effectively communicate regulatory information to both technical and non-technical stakeholders. Strong organizational skills and attention to detail. Ability to work independently and as part of a team in a fast-paced environment.
• Adaptability: Ability to work in a dynamic and evolving regulatory environment, managing multiple priorities and deadlines.

Compensation and Benefits:

The well-being of our employees and their families is of the highest importance. As such, we offer a competitive salary and exceptional benefits, including generous stock options, medical, dental, vision, disability, life insurance, and significant PTO.

Sr. Associate, Regulatory Affairs (Grade Level 7) Salary: $117,000 - $143,000 per year

Compensation will vary depending on location, job-related knowledge, skills, and experience. You may also be offered a bonus, stock options, and benefits. These ranges are subject to change.

We are an equal opportunity employer. All applicants will be considered for employment without attention to age, race, color, religion, sexual orientation, gender identity, national origin, veteran or disability status, or any classification protected by federal, state, or local laws.

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