Senior Director, Global Regulatory Affairs

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

The Senior Director, Global Regulatory Affairs oversees day-to-day operations within the Regulatory Affairs Team, including preparation and maintenance of documentation to ensure effective and timely regulatory submissions worldwide.  This role serves as a strategic partner to executive leadership, providing regulatory guidance across all areas of the company (CMC, quality, regulatory, clinical, and business development) and establishing regulatory frameworks that support business objectives while ensuring compliance with Regulatory Agency/Health Authority requirements across global markets.

How You Contribute

• Oversee preparation and maintenance of complex regulatory submission packages (e.g., IND/CTA, Orphan Drug, Annual Reports, MAA/BLA, meeting packages) across multiple global jurisdictions (US, EU, and others) and development programs simultaneously
• Craft essential documents supporting global regulatory submissions and strategic goals
• Lead comprehensive review of scientific and technical documents supporting development programs and regulatory submissions to ensure accuracy, consistency, and regulatory compliance
• Lead efforts to support high-quality responses to information requests from global regulatory agencies
• Cultivate and maintain senior-level relationships with global regulatory agencies, consultants, KOLs, and CROs, as required
• Serve as a senior Regulatory Affairs representative at cross-functional product development team meetings and R&D review meetings 
• Direct regulatory intelligence initiatives to inform strategic decision making and market positioning.  
• Provide expert regulatory guidance during internal and external audits
• Utilize and oversee regulatory intelligence databases (e.g., Clarivate's Cortellis platform) to inform global regulatory strategies
• Perform regulatory impact assessments and peer analysis to anticipate regulatory challenges. 
• Lead comprehensive global regulatory strategies for obtaining registrations in target countries worldwide, including detailed timelines, resource allocation, and cost projections aligned with business objectives
• Perform other duties as required by the needs of the company and the Regulatory Affairs team

 What You Bring to the Team

Education & Experience

• Bachelor’s degree in biological sciences, chemistry or related field; advanced degree preferred
• 12 years of regulatory experience with demonstrated global regulatory expertise and direct experience with complex submissions in multiple jurisdictions
• Experience with gene therapy development preferred
• An equivalent combination of education and experience is acceptable 

Competencies

• Demonstrated expertise in global regulatory frameworks and requirements (FDA, EMA, ICH, PMDA, Health Canada, NMPA, ANVISA, TGA)
• Expertise in regulatory publishing and submission management systems is preferred
• Exceptional written, oral, and interpersonal communication skills with the ability to independently and expertly present complex technical and strategic content to senior leadership, regulatory agencies, and other critical stakeholders
• Proven ability to manage multiple complex regulatory projects simultaneously across different time zones, consistently ensuring timely, complete, and high-quality submission packages

Working Conditions 

• Primarily desk-based, generally in an office environment
• 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.