Senior Director, Regulatory CMC

Perspective Therapeutics

Senior Director of Regulatory CMC providing strategic leadership for radiopharmaceutical compliance and regulatory submissions. Partnering with teams to ensure CMC readiness across all development stages.

Posted 6/13/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

Provide strategic leadership for global Chemistry, Manufacturing, and Controls (CMC) regulatory strategy across radiopharmaceutical development programs and future commercial products.
Define and execute CMC regulatory strategies, author and oversee Module 3 and Quality sections of regulatory submissions.
Lead health authority interactions related to CMC, radiochemistry, and manufacturing.
Partner with Manufacturing, Quality, Clinical Development, and Technical Operations to ensure CMC readiness across all stages of development.
Provide expert guidance on global regulatory expectations for CMC, particularly for radiopharmaceuticals.
Ensure CMC documentation is scientifically robust, compliant, and aligned with clinical and manufacturing strategy.
Provide leadership on regulatory approach for CMC changes, comparability assessments, process changes, site transfers, and manufacturing evolution.

Requirements

What you’ll need

Bachelor’s degree in a scientific discipline required; advanced degree (PhD, MS, or equivalent) in chemistry, pharmaceutical sciences, radiochemistry, or related field strongly preferred.
Minimum of 12+ years of progressive Regulatory Affairs experience, with significant focus on CMC regulatory strategy and submissions.
Significant hands-on experience in radiopharmaceutical CMC regulatory affairs is required, including support for radiochemistry, manufacturing controls, and quality strategy for clinical and/or commercial programs.
Experience with alpha-emitting radiopharmaceuticals and peptide-based products is strongly preferred.
Demonstrated success leading CMC sections of major global regulatory submissions, including INDs, CTAs/IMPDs, and marketing applications.
Extensive experience interacting with global regulatory agencies (e.g., FDA, EMA), including leading preparation for and participation in formal meetings (e.g., Type B, Type C).
Strong experience working cross-functionally with Manufacturing, Technical Operations, and Quality organizations.
Experience with CMC change management, comparability, site transfers, technical transfers, and/or commercialization readiness strongly preferred.
Experience working with internal and external manufacturing networks, including CDMOs and contract testing laboratories, strongly preferred.

Benefits

Comp & perks

Remote, home-based position
Flexibility to support meetings across time zones
Professional development opportunities
Equal employment opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategyCMC regulatory submissionsradiochemistrymanufacturing controlsquality strategyalpha-emitting radiopharmaceuticalspeptide-based productsCMC change managementcomparability assessmentscommercialization readiness

Soft Skills

strategic leadershipcross-functional collaborationexpert guidanceinterpersonal communicationorganizational skillsproblem-solvingteam leadershipstakeholder engagementproject managementdecision-making

Certifications

Bachelor’s degreePhDMSRegulatory Affairs Certification (RAC)