Associate Director, Regulatory Affairs at Kriya Therapeutics Inc – Morrisville, North Carolina

About Kriya

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.

We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.

We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.”

Who You Are

Associate Director, Regulatory Affairs manages day-to-day operations within the Regulatory Affairs Team, including preparation and maintenance of documentation to ensure effective and timely regulatory submissions. The Associate Director, Regulatory Affairs works on assignments across all areas of company (CMC, quality, regulatory, clinical, and business) in coordination with other teams to ensure compliance with Regulatory Agency/Health Authority requirements.

How You Contribute

• Manage preparation and maintenance of regulatory submission packages (e.g., IND/CTA, Orphan Drug, Annual Reports, MAA/BLA, meeting packages) across multiple global jurisdictions (US, EU, and others) simultaneously
• Prepare cover letters, forms, and other documents supporting regulatory submissions
• Review scientific and technical documents supporting development programs and regulatory submissions to ensure accuracy, consistency, and regulatory compliance
• Support high-quality and timely responses to information requests from regulatory agencies through research and data collection, establishing/managing timelines, and coordinating team member contributions
• Act as a primary point of contact with global regulatory agencies, consultants, and CROs, as required
• Represent the Regulatory Affairs team at cross-functional product development team meetings and R&D review meetings
• Maintain up-to-date knowledge and competency with global regulatory requirements and provide timely and accurate regulatory guidance to internal teams and global affiliates
• Provide regulatory support during internal and external audits
• Utilize regulatory intelligence databases (e.g., Clarivate’s Cortellis platform) to support regulatory decision making
• Help develop best practices for Regulatory Affairs processes and assist with their implementation
• Assist with researching and implementing regulatory strategies in target countries, including developing timelines and cost projections aligned with business objectives
• Participate in peer-review studies to determine possible regulatory implications
• Maintain regulatory submission/communication archives
• Perform other duties as required by the needs of the company and the Regulatory Affairs team

What You Bring to the Team

• Bachelor’s degree in biological sciences, chemistry or related field; advanced degree preferred
• 8+ years of regulatory experience, including with global regulatory submissions
• Experience with gene therapy development preferred
• An equivalent combination of education and experience is acceptable

Competencies

• Highly knowledgeable about global regulatory frameworks, current submission requirements, and best practices (FDA, EMA, ICH, GxP guidelines, and others)
• Hands-on experience with regulatory publishing and submission management systems is preferred
• Strong written, oral, and interpersonal communication skills
• Able to remain organized while coordinating multiple projects

Working Conditions

• Primarily desk-based, generally in an office or home office setting
• May involve extended periods of sitting and computer use.

Discover True Collaborative Teamwork

We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day. We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.

What We Offer

Medical, Dental and Vision ∙ 401(k) with Company Match ∙ Short and Long-term Disability Benefits ∙ Company Paid Holidays ∙ Flexible Time Off ∙ Cyber Safety protection ∙ EAP ∙ Life Insurance ∙ Equity ∙ and more!

Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.