Associate Director, Regulatory Affairs (CMC)

Kriya Therapeutics•Morrisville, NC

1d•Hybrid

About The Position

The Associate Director, Regulatory Affairs (CMC) works closely with the functional areas supporting manufacturing 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.

Requirements

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.
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.

Nice To Haves

Experience with AAV gene therapy is preferred.
Experience with additional global regulatory authorities beyond US FDA is preferred.

Responsibilities

Provide expert CMC regulatory guidance to shape global regulatory strategies, including risk management and compliance requirements, for multiple programs.
Serve as an author and/or reviewer for global regulatory dossiers.
Drive regulatory interactions with health authorities at all stages of development, including pre-submission meetings, responses to information requests, and other formal communications.
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 and interpret their impact on Kriya’s manufacturing operations and program strategies.
Lead the acquisition, development, and deployment of regulatory intelligence, infrastructure, and processes to advance regulatory activities companywide.