Northeastern University · 4 months ago
Ironwood Pharmaceuticals-Regulatory Affairs Postdoctoral Research Fellow
Boston, MA (Main Campus)
Full-time
Onsite
New Grad, Entry Level
$59K/yr - $84K/yrNortheastern University is offering a two-year Regulatory Affairs PharmD fellowship in partnership with Ironwood Pharmaceuticals, a biotechnology company focused on developing therapies for gastrointestinal and rare diseases. The fellowship aims to train PharmD graduates in Global Regulatory Affairs, providing them with hands-on experience in regulatory submissions, strategy, and collaboration across various functional areas.
Education
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
Qualification
Required
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
Preferred
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 one's strengths and weaknesses, proactively asking for feedback to balance self-perception, and being resilient in order to increase one's 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
Benefits
Medical
Vision
Dental
Paid time off
Tuition assistance
Wellness & life
Retirement-
Commuting & transportation
Company
Northeastern University
Founded in 1898, Northeastern is a global research university with a distinctive, experience-driven approach to education and discovery.
Founded in 1898
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Angela Hosking
CEO Regional Dean
Dave Thurman
Dean & CEO, Seattle Campus
Recent News
2024-01-06
Alfred P. Sloan Foundation
2023-10-30
Company data provided by crunchbase