Regulatory Affairs/Operations Consultant in Morrisville, North Carolina at Kriya Therapeutics Inc

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

How You Contribute

• Manage preparation of submission documents, including cover letters, forms, and regulatory maintenance documents (e.g., IND/CTA, Orphan Drug, Annual Reports)
• Represent Regulatory Affairs department at cross-functional product development team meetings, participate in R&D review meetings, and provide regulatory guidance
• Coordinate with cross-functional team members to facilitate scheduling and completion of regulatory document authoring and review of INDs, CTAs, BLAs, designation requests, etc.
• Research and collect data to support authoring of responses to requests for information from regulatory agencies, to prepare and submit documentation for marketing approvals, as well as provide routine regulatory information to associates and affiliates.
• Experience with a regulatory intelligence database (e.g., Clarivate’s Cortellis platform) is a plus
• Accountable for the development and implementation of best practices for Regulatory Affairs processes.
• Maintain regulatory submission/communication archives.
• Provide Regulatory Affairs support during internal and external audits.
• Assist with data call-ins and other information requests from regulatory agencies
• Implements the development of strategies for obtaining registrations in target countries, including timelines and costs for achievement of registrations in line with business objectives.
• Participation in peer review studies to determine possible regulatory implications.
• Perform other related 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; advanced degree preferred
• 8+ years of regulatory experience
• An equivalent combination of education and experience is acceptable

Competencies

• Proficiency in current and new regulatory policies and decisions (FDA, EMA, ICH, GxP guidelines, etc.).
• Experience with regulatory publishing
• 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.

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.