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Northeastern University · 3 months ago

Takeda-Global Regulatory Affairs Postdoctoral Research Fellow

Boston, MA

Full-time

Onsite

New Grad

$59K/yr - $84K/yr

Northeastern University is offering a two-year Global Regulatory Affairs fellowship in partnership with Takeda, aimed at advancing Pharm.D. graduates' education and training. The role involves developing regulatory strategies, supporting regulatory activities for plasma-derived therapies, and gaining expertise in clinical development and global regulatory affairs.

Education

Growth Opportunities

Responsibilities

Regulatory Strategy Development: Interpret and apply relevant regulations and guidelines to assist in the creation and implementation of effective regulatory strategies

Life-Cycle Management: Support pre- and post-approval regulatory activities for plasma-derived therapies, including preparation and submission of documentation to health authorities

Clinical Development Support: Gain expertise in regulatory requirements for both early- and late-phase clinical development programs

Global Regulatory Affairs Exposure: Develop understanding across key functional areas, including labeling, regulatory strategy, and chemistry, manufacturing, and controls (CMC)

Labeling Management: Aid in strategic guidance on product labeling throughout the product life cycle

Process Improvement Initiatives: Actively participate in projects to improve efficiency and compliance

Agency Review Understanding: Build knowledge of agency review principles to facilitate effective submissions and interactions with regulatory bodies