Takeda-Global Regulatory Affairs Postdoctoral Research Fellow

Northeastern University • Newton, MA

132d • $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, Takeda is offering a two-year Global Regulatory Affairs- Plasma Derived Therapy fellowship, based in Cambridge, MA.

Requirements

• Doctor of Pharmacy degree from an ACPE-accredited institution.
• 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.
• Open to applications from U.S. PhD degree candidates.

Responsibilities

• Interpret and apply relevant regulations and guidelines to assist in the creation and implementation of effective regulatory strategies.
• Support pre- and post-approval regulatory activities for plasma-derived therapies, including preparation and submission of documentation to health authorities.
• Gain expertise in regulatory requirements for both early- and late-phase clinical development programs.
• Develop understanding across key functional areas, including labeling, regulatory strategy, and chemistry, manufacturing, and controls (CMC).
• Aid in strategic guidance on product labeling throughout the product life cycle.
• Actively participate in projects to improve efficiency and compliance.
• Build knowledge of agency review principles to facilitate effective submissions and interactions with regulatory bodies.

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• Paid time off
• Tuition assistance
• Wellness & life benefits
• Retirement benefits
• Commuting & transportation benefits

What This Job Offers

• Education Level: Ph.D. or professional degree