Associate Director, Regulatory Affairs (CMC)

Kriya Therapeutics

Kriya Therapeutics

Legal
Morrisville, NC, USA
Posted on Tuesday, March 5, 2024

Who You Are

The Associate Director, Regulatory Affairs (CMC) works closely with the manufacturing department and individual program teams to ensure CMC compliance and promote overall regulatory success. The Associate Director, Regulatory Affairs (CMC) possesses strong leadership skills, broad knowledge of multiple aspects of regulatory affairs (beyond CMC) across all phases of drug development, and a deep understanding of global CMC regulations, including GMP and region-specific guidelines, especially as they relate to gene therapies.

How You Contribute

  • Provide expert CMC regulatory advice to support the development and implementation of global regulatory strategies, including risk management and compliance requirements, for multiple programs
  • Act as the primary regulatory lead providing comprehensive regulatory affairs support (i.e., beyond CMC) to one or more program teams
  • Support the planning and construction of global regulatory dossiers, including as author and/or reviewer
  • Support regulatory interactions (e.g., meetings with regulatory bodies) at all stages of development
  • Act as a primary point of contact for regulatory affairs both internally and with external stakeholders and global regulatory authorities
  • Proactively monitor changes in the global CMC regulatory environment, interpreting their implications for manufacturing at Kriya and individual program teams
  • Support the acquisition, development, and deployment of regulatory intelligence, infrastructure, and processes to support regulatory activities companywide

What You Bring to the Team

Education & Experience

  • Advanced degree in a science-related field and/or other appropriate knowledge, training, and experience
  • At least 8 years of experience in regulatory drug development in the pharmaceutical/biotechnology industry with a primary focus on CMC regulations and compliance across the development lifecycle
  • Experience with AAV gene therapy is preferred
  • Experience with additional global regulatory authorities beyond US FDA is preferred

Competencies

  • Knowledgeable of current US regulatory requirements and ICH guidelines with an understanding of current global and regional trends in regulatory affairs
  • Experience authoring/reviewing regulatory dossiers, including CMC, clinical, nonclinical, and administrative content for IND/CTA and BLA/MAA filings
  • Ability to think strategically and critically evaluate regulatory risks
  • Ability to work effectively, both independently and collaboratively, within multiple complex, high-profile, and fast-paced development programs simultaneously
  • Excellent oral and written communication skills
  • Excellent interpersonal skills, flexibility, and adaptability

Working Conditions and Physical Demands

  • Work is normally performed: at a desk
  • Lifting requirements: None
  • Travel requirements: Occasional
  • Working outside of normal working hours may be necessary on occasion (e.g., when approaching a regulatory filing deadline) but is not otherwise expected or encouraged.

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.

What We Offer

Medical, Dental and Vision with 100% employee premium coverage Retirement matching Short and long-term disability benefits 12 company paid holidays Generous Time Off Cyber Safety protection EAP Company paid 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.