Postdoctoral Research Fellow-Ironwood Pharmaceuticals, Regulatory Affairs
Core
Two-year experiential fellowship for Pharm.D. graduates to train in Global Regulatory Affairs at Ironwood Pharmaceuticals, preparing them for industry roles.
Role type
Postdoctoral Research Fellow (Regulatory Affairs)
Builds
Regulatory strategies, submission documents (IND/CTA/NDA), and agency meeting materials for GI and rare disease therapies.
Domain
Biopharmaceuticals / Gastrointestinal and Rare Diseases
Deliverable
client delivery
Required skills
Regulatory strategy, IND/CTA/NDA/MAA preparation, agency meeting management, regulatory intelligence, vendor oversight, compliance metrics, project management
Preferred skills
None stated
Technologies
Microsoft Office Suite (Excel, Outlook, PowerPoint, Word)
Responsibilities
Assist in planning and coordinating regulatory submissions for clinical trials and product registrations; Develop regulatory strategies for assigned projects; Prepare briefing books and documents for regulatory agency meetings; Collaborate with internal teams and vendors for inspections and audits; Keep abreast of regulatory environment changes in US and international jurisdictions.
Seniority
Entry-level Fellow (training focus)
