Jobs at Inhibikase Therapeutics

The Associate Director, Regulatory Affairs, will oversee and coordinate global regulatory activities supporting Inhibikase Therapeutics development programs. This role ensures the timely planning, preparation, submission, and tracking of regulatory deliverables across regions (e.g., FDA, Health Canada, EMA, MHRA, TGA), working in close partnership with internal teams and external vendors.

Regulatory Planning & Execution:

• Develop and manage detailed regulatory project plans, including timelines, deliverables, and dependencies for IND, CTA, and NDA-related submissions.
• Coordinate preparation, QC, and dispatch of regulatory submissions and responses to health authority queries.
• Track deliverable progress, identify risks or delays, and proactively drive issue resolution to meet filing timelines.

Cross-Functional Leadership:

• Serve as the central point of contact among Regulatory, CMC, Clinical, Nonclinical, QA, Medical Writing, and CRO partners.
• Facilitate team meetings, define next steps, assign responsibilities, and ensure completion of follow-up actions.
• Align submission content, format, and messaging across global health authority requirements.

Agency Interaction Support:

• Support preparation of briefing packages and logistics for FDA, EMA, and Health Canada meetings (Type B/D, Scientific Advice, etc.).
• Coordinate collection and finalization of meeting materials, minutes, and correspondence.

Labeling & Lifecycle Management:

• Support global and regional labeling updates, including alignment with reference labels and core data sheets.
• Oversee post-approval and maintenance activities such as amendments, variations, and annual updates.

Compliance & Documentation:

• Ensure adherence to relevant health authority guidelines and internal SOPs.
• Maintain document control, version tracking, and submission history within regulatory information management systems.
• Monitor regulatory intelligence and communicate key updates impacting project timelines or requirements.

• 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 a pharmaceutical or biotech environment.
• Proven record in coordinating major submissions (INDs, CTAs, NDAs) and supporting global regulatory interactions.
• Small molecule experience is required.
• Strong knowledge of Health Canada, FDA, and EMA processes and expectations.
• Skilled in Smartsheet, MS Project, Excel trackers, and regulatory document control systems (eCTD, RIM).
• Excellent communication, organization, and stakeholder management skills with a strong attention to detail.
• Highly organized, timeline-driven, and proactive in issue identification and resolution.
• Effective cross-functional facilitator with the ability to influence without authority.
• Adept at managing multiple priorities in a dynamic, fast-paced environment.
• Committed to operational excellence and continuous process improvement.
• Knowledge in cardio-pulmonary therapeutic area relevant to Inhibikase’s portfolio a plus.
• Additional certifications a plus.