Job Description

divh2Program Overview/h2pNortheastern 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./ppFellows 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./ppIn partnership with Northeastern University, Ironwood Pharmaceuticals is offering a two-year Regulatory Affairs PharmD fellowship based in Boston./ph2About Ironwood Pharmaceuticals/h2pIronwood 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. Building upon our history of innovation, we keep patients at the heart of our RD and commercialization efforts to reduce the burden of diseases and address significant unmet needs./ppFounded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, with a site in Basel, Switzerland./ph2Position Description/h2pThe 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./ppDuring the fellowship, the fellow will work within Regulatory Affairs to gain experience in:/pulliMaintenance of IND/CTAs and/or NDAs/MAAs/liliRegulatory strategy/liliRegulatory intelligence/liliAgency meeting management and correspondence/liliGlobal/regional labeling/liliRegulatory operations/li/ulpThe 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./ppAdditionally, the fellow will have the opportunity to attend meetings and conferences, present guidance reviews, and other opportunities as they arise./ph2Key Responsibilities/h2ulliAssist in the planning and coordinating all aspects of regulatory submissions necessary to support clinical trials, product registrations, and post marketing requirements and commitments/liliAssist 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/liliAssist 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/liliSupport 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/liliWork with Regulatory Operations team members to establish and meet timelines for regulatory submissions/liliKeep abreast of and communicate changes and meaningful trends in the regulatory environment in the US and pertinent international jurisdictions/liliSupport and participate in the development of Regulatory Department systems and processes/liliAssist with performance and compliance metrics for internal and external responsibilities/liliCollaborate with internal teams and vendors to prepare for inspections and audits/liliPresent and assist in coordinating guidance reviews and other presentations/liliInteract with partners and engage in vendor oversight as required/liliParticipate in fellowship recruitment activities and interviews/liliAdditional responsibilities to be assigned based on individual interests or as business needs require/li/ulh2Required Qualifications/h2ulliDoctor of Pharmacy (PharmD) from an ACPE-accredited institution before the start of the fellowship term/liliEligible for pharmacist licensure in the State of Massachusetts/liliExcellent oral and written communication skills/liliStrong time management and leadership abilities/liliAbility to work independently and take initiative on a variety of projects at both the industry site and Northeastern/li/ulh2Desired Candidate Attributes/h2ulliMotivation to learn new skills and gain experience within Global Regulatory Affairs/liliAbility to interpret and discuss regulations and guidelines related to drug development/liliAbility to interpret and discuss medical, epidemiological, and clinical data and publications/liliAbility to perform the assigned activities in full compliance with applicable regulations and internal procedures/liliAbility 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/liliAbility 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/liliExcellent interpersonal skills in order to effectively manage expectations and facilitate collaborative working relationships/liliAbility to recognize opportunities and/or issues and apply analytical and creative thinking to maximize performance/liliExcellent 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/liliProficiency and experience with Microsoft Office Suite, especially Excel, Outlook, PowerPoint, and Word/li/ulh2Application Requirements/h2h3Documents to Submit by October 31, 2025 (Priority Deadline):/h3ullistrongCurriculum vitae (CV)/strong/lilistrongUnofficial PharmD transcripts/strong/lilistrongCover letter/strong/lilistrongLetter of intent/strong - describing why the candidate would like to join Ironwoods Fellowship program/li/ulh3Letters of Recommendation/h3pstrongThree formal letters of recommendation/strong must be sent directly from the letter writer to:/pullistrongEmail:/strong PharmDFellowships@northeastern.edu/lilistrongDeadline:/strong November 21, 2025/lilistrongSubject Line Format:/strong Smith, John Ironwood Pharmaceuticals/li/ulh3Address all correspondence to:/h3pstrongJ. Andrew Orr-Skirvin, PharmD, BCOP/strong Clinical Professor, Department of Pharmacy Health Systems Sciences Pharmaceutical Industry Fellowship Program Director 360 Huntington Ave, 140 The Fenway R218 Boston, MA 02115/ppIronwood Pharmaceuticals is an equal opportunity employer, welcoming diversity in our workforce./ppPosition Type: Research/ppNortheastern University considers factors such as candidate work experience, education and skills when extending an offer./ppNortheastern 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 a rel=noopener noreferrer href= target=_blank for more information./ppAll 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/p/div

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