Postdoctoral Research Fellow-Ironwood Pharmaceuticals, Regulatory Affairs

About the Opportunity

Northeastern University Pharmaceutical Industry Fellowships Program is a two-year experiential program designed to advance lifelong learning and the education and training of Pharm.D. graduates. A key element of the program's success is preparing Fellows to meet evolving workforce needs across various sectors of the pharmaceutical industry.

Fellows have the opportunity to work closely with our innovative biopharmaceutical industry partners, while engaging with Northeastern University faculty in professional and career development, teaching, service, and scholarly activities.

In partnership with Northeastern University, Ironwood Pharmaceuticals is offering a two-year Regulatory Affairs PharmD fellowship based in Boston.

About Ironwood Pharmaceuticals

Ironwood Pharmaceuticals is a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases. Ironwood is advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for short bowel syndrome patients who are dependent on parenteral support. In addition, Ironwood has been a pioneer in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). LINZESS is also approved for the treatment of functional constipation in pediatric patients ages 6-17 years old.

Responsibilities

The purpose of the Regulatory Affairs (RA) Fellowship is to provide the fellow with training in the functional area and to prepare them to enter an industry role as an individual contributor in Global Regulatory Affairs after the end of their 2-year fellowship.

• Assist in the planning and coordinating all aspects of regulatory submissions necessary to support clinical trials, product registrations, and post marketing requirements and commitments
• Assist in the development of regulatory strategies for assigned projects or product(s) across all phases of product development
• Assist in planning, authoring, reviewing and preparing investigational new drugs (INDs) / clinical trial applications (CTAs), new drug applications (NDAs), Marketing Authorization Applications (MAAs), and related annual reports, amendments, supplements, and other activities required for life-cycle management of approved products

Qualifications

• Doctor of Pharmacy degree from an ACPE-accredited institution
• Eligible for pharmacist licensure in the State of Massachusetts

Additional Information

Applicants should submit the following application materials: Curriculum vitae (CV), unofficial PharmD transcripts, cover letter, letter of intent. Three formal letters of recommendation should be sent directly to PharmDFellowships@northeastern.edu by July 1, 2026.