Intern - Regulatory Affairs

Company Summary:

Kriya is a next-generation gene therapy company focused on expanding the field to new frontiers. We have built a fully integrated, technology-enabled platform for rational vector design, analytical characterization, and scalable manufacturing to design and develop gene therapies for diseases with well-understood underlying biology. We believe that rationally engineered gene therapies can transform the treatment of a broad universe of diseases – and we are prepared to lead this revolution in medicine.

Our team is made up of leading scientific experts who are passionate about improving patients’ lives and easing the burden of these life-changing disorders for patients. We are looking for teammates with the ambition, creativity, and energy to help us build a unique organization.

If you are looking to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, Kriya is the company for you.

Position Summary:

We are seeking an independent and highly organized summer intern to join the Regulatory Affairs team at Kriya. The intern will contribute to preparation and maintenance of regulatory documents to help ensure effective and timely regulatory submissions across Kriya’s pipeline of gene therapy programs. This internship is an excellent opportunity to gain direct experience working in an industry setting across functional areas of drug development (Regulatory, CMC, Quality, Clinical, Preclinical), gain exposure to global regulatory strategic planning, and support upcoming regulatory milestones for the company.

Primary Responsibilities:

The intern will work collaboratively with the Regulatory Affairs team and with cross-functional teams on day-to-day operations that support the preparation and maintenance of regulatory documents. The intern will:

• Support authoring of regulatory submission documents and preparation for regulatory interactions with global health authorities
• Support regulatory and clinical trial intelligence requests from program teams and/or Kriya leadership
• Perform literature searches and information gathering to obtain background information for development of regulatory documents and support strategic program decisions
• Support development of templates for standardization of documents
• Perform additional activities that involve regulatory support as they arise

Required Qualifications:

• Master’s degree or PhD (or PhD candidate) in life sciences/biological sciences and/or regulatory sciences
• Familiarity with current regulatory policies and guidelines (FDA, EMA, ICH, GxP) is a plus, but not required
• Experience with drug development is a plus, but not required
• Must demonstrate excellent verbal, written, and interpersonal communication skills
• Ability to work independently and as part of a cross-functional team
• Competency with Microsoft Office programs

Working Conditions:

• Work is normally performed in a typical office work environment
• This is a hybrid role consisting of 2 days per week, in office. (remote only possible).

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.