CMC Regulatory Affairs Specialist

$90,000 - $110,000/Yr

Spectronrx - Indianapolis, IN

Full-time - Mid Level

Indianapolis, IN

Ambulatory Health Care Services

About the position

The CMC Regulatory Affairs Specialist at SpectronRx is responsible for ensuring compliance with regulatory requirements for radiopharmaceuticals. This role involves regulatory assessment of changes, preparation of regulatory submissions, and collaboration with various teams to maintain high standards in product development. The specialist will work closely with pharmaceutical partners to ensure that products are produced reliably and in compliance with regulations, specifically 21 CFR 212 and 211.

Responsibilities

• Perform regulatory assessment of changes for radiopharmaceuticals.
• Generate regulatory documentation including SOPs, Master Batch Records, and QC Records.
• Review regulatory submissions for global regulatory and CMC compliance.
• Support regulatory submission forms for regulatory release and QP certification.
• Ensure adherence to SpectronRx's Change Control procedure.
• Contribute to CAPA procedures as required.
• Assist in the preparation of regulatory submissions such as BLAs, DMFs, INDs, and NDAs.
• Develop realistic timelines for new radiopharmaceutical introductions in collaboration with partners.
• Manage resources and timelines through project management practices.
• Compile and submit reports on all projects to management and customers.

Requirements

• Advanced degree in organic, analytical or radiochemistry or related fields.
• Minimum 2 years of experience in PET/SPECT radiopharmaceuticals.
• Strong project management skills in contract manufacturing.
• Expertise in 21 CFR 212 and 211 regulations.
• Excellent organizational skills and attention to detail.
• Ability to communicate professionally and effectively in a fast-paced environment.

Nice-to-haves

• Experience with analytical techniques such as radio-TLC, GC, and endotoxin analysis.
• Experience with aseptic filling.

Benefits

• Health insurance
• Dental insurance
• 401(k)
• Paid time off
• Vision insurance