Ironwood Pharmaceuticals-Regulatory Affairs Postdoctoral Research Fellow

About the Opportunity

Program Overview

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 programs 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 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. Building upon our history of innovation we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of diseases and address significant unmet needs.

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

Position Description

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 functions 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

• 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.

Additionally the fellow will have the opportunity to attend meetings and conferences present guidance reviews and other opportunities as they arise.

Key Responsibilities:

• 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 aimed at achieving marketing authorization and appropriate product labeling

• 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

• 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

• Support and participate in the development of Regulatory Department systems and processes

• Assist with performance and compliance metrics for internal and external responsibilities

• 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

• Additional responsibilities to be assigned based on individual interests or as business needs require

Required Qualifications:

• Doctor of Pharmacy (PharmD) from an ACPE-accredited institution before the start of the fellowship term

• 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

Desired Candidate Attributes:

• Motivation to learn new skills and gain experience within Global Regulatory Affairs

• Ability to interpret and discuss regulations and guidelines related to drug development

• Ability to interpret and discuss medical epidemiological and clinical data and publications

• Ability to perform the assigned activities in full compliance with applicable regulations and internal procedures

• Ability to leverage a deep understanding of oneself through knowing ones strengths and weaknesses proactively asking for feedback to balance self-perception and being resilient in order to increase ones effectiveness

• Ability to work cooperatively with colleagues and take initiative to build relationships despite differences in interest offering support and help to peers without being asked and proactively seeking input from others to solve problems

• Excellent interpersonal skills in order to effectively manage expectations and facilitate collaborative working relationships

• Ability to recognize opportunities and/or issues and apply analytical and creative thinking to maximize performance

• Excellent written and verbal communication skills as well as organizational and project management skills ability to function in an extremely fast-paced environment with changing priorities

• Proficiency and experience with Microsoft Office Suite especially Excel Outlook PowerPoint and Word

:Application Requirements

Documents to Submit by October 31 2025 (Priority Deadline):

• Curriculum vitae (CV)

• Unofficial PharmD transcripts

• Cover letter

• Letter of intent - describing why the candidate would like to join Ironwoods Fellowship program

Letters of Recommendation:

Three formal letters of recommendation must be sent directly from the letter writer to:

• Email:

• Deadline: November 21 2025

• Subject Line Format: Smith John Ironwood Pharmaceuticals

Address all correspondence 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

Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.

Position Type

Additional Information

Northeastern University considers factors such as candidate work experience education and skills when extending an offer.

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: