Postdoctoral Research Fellow-Ironwood Pharmaceuticals, Regulatory Affairs

About The Opportunity

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

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. Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, with a site in Basel, Switzerland.

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.
• By gaining experience in Global Regulatory Affairs, the fellow will be able to pursue a successful career in the Regulatory Affairs and will have a practical understanding of the other function’s responsibilities to enable them to be an optimal collaborator and colleague.
• During the fellowship, the fellow will work within Regulatory Affairs to gain experience in maintenance of IND/CTAs and/or NDAs/MAAs, regulatory strategy, regulatory intelligence, Agency meeting management and correspondence, global/regional labeling, and regulatory operations.
• The fellow will have the opportunity to work collaboratively with other functional areas within Ironwood, including global patient safety, clinical development, medical scientific affairs, program management, data sciences, quality and compliance, nonclinical, medical writing and publications, and chemistry, manufacturing, and controls, as well as experience partner interactions and engage in vendor oversight.
• The fellowship training will enable them to collaborate effectively with colleagues across various disciplines which is essential to both the development of a therapeutic product and management of that product throughout its lifecycle.
• The fellow will have the opportunity to attend meetings and conferences, present guidance reviews, and other opportunities as they arise.
• Additional Responsibilities:
  • Aid in the planning and coordinating all aspects of regulatory submissions necessary to support clinical trials, product registrations, and post marketing requirements and commitments.
  • Develop regulatory strategies for assigned projects or product(s) across all phases of product development aimed at achieving marketing authorization and appropriate product labeling.
  • Plan, author, review, and prepare 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.
  • Support the preparation for regulatory agency meetings for assigned products, including meeting plan, development of briefing books, and ensuring submitted documents are compliant and of the highest quality.
  • Work with Regulatory Operations team members to establish and meet timelines for regulatory submissions.
  • Keep abreast of and communicate changes and meaningful trends in the regulatory environment in the US and pertinent international jurisdictions.
  • Assist in the development of Regulatory Department systems and processes.
  • Collaborate with internal teams and vendors to prepare for inspections and audits.
  • Present and assist in coordinating guidance reviews and other presentations.
  • Interact with partners and engage in vendor oversight as required.
  • Participate in fellowship recruitment activities and interviews.

Qualifications

• Doctor of Pharmacy degree from an ACPE-accredited institution.
• Eligible for pharmacist licensure in the State of Massachusetts.
• Excellent oral and written communication skills.
• Strong time management and leadership abilities.
• Ability to work independently and take initiative on a variety of projects at both the industry site and Northeastern.

Additional Information

Applicants Should Submit The Following Application Materials:

• Curriculum vitae (CV), uploaded
• Unofficial PharmD transcripts, uploaded
• Cover letter, uploaded
• Letter of intent describing why the candidate would like to join Ironwood’s Fellowship program
• Three formal letters of recommendation (LORs) should be sent directly from the letter writer to PharmDFellowships@northeastern.edu by July 1, 2026. LOR writers must include the candidate’s name and the fellowship program(s) in the subject line (e.g., Smith, John – Ironwood Pharmaceuticals).

Address the cover letter, letter of intent, and letters of recommendation to:

J. Andrew Orr-Skirvin, PharmD, BCOP Clinical Professor, Department of Pharmacy & Health Systems Sciences Pharmaceutical Industry Fellowship Program Director 360 Huntington Ave, 140 The Fenway R218 Boston, MA 02115

Position Type

Research

Additional Information

Northeastern University considers factors such as candidate work experience, education and skills when extending an offer. Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement- as well as commuting & transportation. Visit https://hr.northeastern.edu/benefits/ for more information.

All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.

Compensation Grade/Pay Type

108S

Expected Hiring Range

$60,315.00 - $85,192.50