Global Regulatory Submissions Lead - Associate Director

Inhibikase Therapeutics, Inc.; United States; On-site; USD 140,000 - 180,000; Full time

Job summary

Inhibikase Therapeutics, Inc. seeks an Associate Director of Regulatory Affairs to oversee global regulatory activities for multiple programs.

You will plan, prepare, submit, and track regulatory deliverables across regions in close collaboration with internal teams and external vendors. Lead cross‑functional teams to align content and messaging with health authority requirements, support FDA/EMA meetings, and manage labeling and lifecycle activities while ensuring compliant documentation and

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, or related discipline (advanced degree preferred).
• 8–10 years of experience in regulatory affairs or regulatory project management within pharma/biotech.
• Proven track record coordinating INDs, CTAs, NDAs and global regulatory interactions.

Responsibilities

• Regulatory Planning & Execution: develop and manage detailed regulatory project plans for IND/CTA/NDA submissions.
• Cross‑Functional Leadership: coordinate with Regulatory, CMC, Clinical, QA, Medical Writing, and CRO partners.
• Agency Interaction Support: prepare briefing packages and meetings with FDA, EMA, Health Canada.

Skills

Regulatory affairs

Project management

Cross-functional collaboration

Communication

Documentation control

Education

Bachelor’s degree in Life Sciences or Pharmacy

Tools

Smartsheet

MS Project

Excel

eCTD / RIM

Job description

Inhibikase Therapeutics, Inc. seeks an Associate Director of Regulatory Affairs to oversee global regulatory activities for multiple programs.

You will plan, prepare, submit, and track regulatory deliverables across regions in close collaboration with internal teams and external vendors. Lead cross‑functional teams to align content and messaging with health authority requirements, support FDA/EMA meetings, and manage labeling and lifecycle activities while ensuring compliant documentation and