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: 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. 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. 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.  Additionally, the fellow will have the opportunity to attend meetings and conferences, present guidance reviews, and other opportunities as they arise.  Additional 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.  The successful candidate will provide:  ·       Doctor of Pharmacy (PharmD) from an accredited college or university before the start of the fellowship term ·       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