Ironwood Pharmaceuticals-Regulatory Affairs Postdoctoral Research Fellow

Northeastern University • Newton, MA

125d • $59,425 - $83,935

About The Position

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.

Requirements

• 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.

Nice To Haves

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

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.

Benefits

• Medical, vision, dental insurance.
• Paid time off.
• Tuition assistance.
• Wellness & life benefits.
• Retirement benefits.
• Commuting & transportation benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Ph.D. or professional degree