Associate Director, Regulatory Affairs CMC

Skyhawk Therapeutics • Waltham, MA

13h • $170,000 - $230,000

About The Position

Skyhawk Therapeutics is seeking a hands-on, Associate Director, Regulatory Affairs CMC (RegCMC) to support the development and execution of the global RegCMC strategy for Skyhawk's small molecule pipeline. Working closely with the Director, RegCMC, you will help serve as a RegCMC point of contact across the organization, partnering with Pharmaceutical Development, Manufacturing, Quality, and Program teams to deliver high-quality, timely regulatory submissions that advance clinical development and support eventual commercialization. This is an ideal opportunity for a growing RegCMC professional who thrives in fast-paced, science-driven biotech where their work has direct and visible impact.

Requirements

• Advanced degree (MS, PhD, PharmD) in chemistry, pharmaceutical sciences, chemical engineering, or a related discipline; a Bachelor's degree with directly relevant experience will be considered.
• 7+ years of combined Regulatory Affairs CMC and pharmaceutical industry experience.
• Experience contributing to global CMC regulatory strategy for small-molecule programs across one or more stages of development.
• Hands-on authorship of CTD Module 3 content; working familiarity with ICH guidelines and applicable FDA/EMA guidance.
• Experience supporting IND, NDA, or MAA regulatory submissions.
• Ability to work both independently and collaboratively, and to prioritize in a fast-paced biotech environment.
• Strong written and verbal communication skills.

Nice To Haves

• Experience supporting a program through later-stage development or the clinical-to-commercial transition.
• Exposure to both early- and late-stage pipeline assets within the same organization.

Responsibilities

• Support the development and execution of global RegCMC strategies for small-molecule programs across stages of development, from IND through NDA/MAA readiness.
• Identify and work in collaboration with CMC Team to address regulatory risks.
• Monitor evolving global health authority expectations and guidance (FDA, EMA, ICH) and translate them into actionable strategy.
• Author and review all applicable Quality sections for global regulatory filings, including IND/IMPD, annual reports, and briefing documents.
• Support and coordinate responses to CMC information requests with accuracy and timeliness.
• Partner with Pharmaceutical Development, Manufacturing, Quality, and Program Management to provide regulatory input on control strategy, specifications, manufacturing changes, comparability, process validation, and lifecycle management.
• Assist with CDMO and external partner oversight from a regulatory perspective, ensuring alignment with submission commitments.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level