Northeastern University
Ironwood Pharmaceuticals-Regulatory Affairs Postdoctoral Research Fellow
Northeastern University, Boston, Massachusetts, us, 02298
Ironwood Pharmaceuticals-Regulatory Affairs Postdoctoral Research Fellow
Join to apply for the
Ironwood Pharmaceuticals-Regulatory Affairs Postdoctoral Research Fellow
role at
Northeastern University . Program Overview
Northeastern University Pharmaceutical Industry Fellows 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 work closely with 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. Ironwood is also known for LINZESS® (linaclotide), a leading treatment for adults with IBS-C or CIC and approved for functional constipation in pediatric patients aged 6–17. Founded in 1998, Ironwood is headquartered in Boston, MA, 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 the 2-year fellowship. The fellow will gain experience in Global Regulatory Affairs and collaborate with colleagues across disciplines to support development and lifecycle management of therapeutic products. 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 collaborate with other functional areas within Ironwood (e.g., global patient safety, clinical development, medical scientific affairs, program management, data sciences, quality and compliance, nonclinical, medical writing and publications, and CMC) and engage in partner interactions and vendor oversight. The training will enable effective collaboration across disciplines and support product development and lifecycle management. The fellow will have opportunities to attend meetings and conferences, present guidance reviews, and other activities as they arise. Key Responsibilities
Assist in planning and coordinating all aspects of regulatory submissions to support clinical trials, product registrations, and post-marketing requirements Assist in developing regulatory strategies for assigned projects across all phases of development to achieve marketing authorization and appropriate labeling Assist in planning, authoring, reviewing and preparing INDs/CTAs, NDAs, MAAs, and related lifecycle activities Support preparation for regulatory agency meetings, including meeting plans and briefing books, ensuring documents are compliant and high quality Work with Regulatory Operations to establish and meet submission timelines Stay informed on changes and trends in the regulatory environment in the US and relevant international jurisdictions Support 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 coordinate guidance reviews and other presentations Interact with partners and engage in vendor oversight as required Participate in fellowship recruitment activities and interviews Additional responsibilities as assigned based on interests or business needs 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 global Regulatory Affairs skills Ability to interpret and discuss regulations and guidelines related to drug development Ability to interpret clinical data and publications Compliance with applicable regulations and internal procedures Self-awareness, resilience, and proactive collaboration with colleagues Strong interpersonal, communication, and organizational skills Ability to work in a fast-paced environment with changing priorities Proficiency with Microsoft Office Suite (Excel, Outlook, PowerPoint, Word) Application Requirements
Curriculum vitae (CV) Unofficial PharmD transcripts Cover letter Letter of intent describing why the candidate would like to join Ironwood's Fellowship program Letters of Recommendation
Three formal letters of recommendation must be sent directly from the letter writer via email to PharmDFellowships@northeastern.edu with the deadline of November 21, 2025. Subject line format: Smith, John – Ironwood Pharmaceuticals. Address for Correspondence
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. Employment details
Position Type: Research Employment Type: Full-time Job Function: Research, Analyst, and Information Technology Industries: Higher Education Northeastern University and Ironwood Pharmaceuticals are equal opportunity employers. All qualified applicants 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.
#J-18808-Ljbffr
Join to apply for the
Ironwood Pharmaceuticals-Regulatory Affairs Postdoctoral Research Fellow
role at
Northeastern University . Program Overview
Northeastern University Pharmaceutical Industry Fellows 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 work closely with 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. Ironwood is also known for LINZESS® (linaclotide), a leading treatment for adults with IBS-C or CIC and approved for functional constipation in pediatric patients aged 6–17. Founded in 1998, Ironwood is headquartered in Boston, MA, 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 the 2-year fellowship. The fellow will gain experience in Global Regulatory Affairs and collaborate with colleagues across disciplines to support development and lifecycle management of therapeutic products. 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 collaborate with other functional areas within Ironwood (e.g., global patient safety, clinical development, medical scientific affairs, program management, data sciences, quality and compliance, nonclinical, medical writing and publications, and CMC) and engage in partner interactions and vendor oversight. The training will enable effective collaboration across disciplines and support product development and lifecycle management. The fellow will have opportunities to attend meetings and conferences, present guidance reviews, and other activities as they arise. Key Responsibilities
Assist in planning and coordinating all aspects of regulatory submissions to support clinical trials, product registrations, and post-marketing requirements Assist in developing regulatory strategies for assigned projects across all phases of development to achieve marketing authorization and appropriate labeling Assist in planning, authoring, reviewing and preparing INDs/CTAs, NDAs, MAAs, and related lifecycle activities Support preparation for regulatory agency meetings, including meeting plans and briefing books, ensuring documents are compliant and high quality Work with Regulatory Operations to establish and meet submission timelines Stay informed on changes and trends in the regulatory environment in the US and relevant international jurisdictions Support 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 coordinate guidance reviews and other presentations Interact with partners and engage in vendor oversight as required Participate in fellowship recruitment activities and interviews Additional responsibilities as assigned based on interests or business needs 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 global Regulatory Affairs skills Ability to interpret and discuss regulations and guidelines related to drug development Ability to interpret clinical data and publications Compliance with applicable regulations and internal procedures Self-awareness, resilience, and proactive collaboration with colleagues Strong interpersonal, communication, and organizational skills Ability to work in a fast-paced environment with changing priorities Proficiency with Microsoft Office Suite (Excel, Outlook, PowerPoint, Word) Application Requirements
Curriculum vitae (CV) Unofficial PharmD transcripts Cover letter Letter of intent describing why the candidate would like to join Ironwood's Fellowship program Letters of Recommendation
Three formal letters of recommendation must be sent directly from the letter writer via email to PharmDFellowships@northeastern.edu with the deadline of November 21, 2025. Subject line format: Smith, John – Ironwood Pharmaceuticals. Address for Correspondence
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. Employment details
Position Type: Research Employment Type: Full-time Job Function: Research, Analyst, and Information Technology Industries: Higher Education Northeastern University and Ironwood Pharmaceuticals are equal opportunity employers. All qualified applicants 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.
#J-18808-Ljbffr