"Takeda-Global Regulatory Affairs Postdoctoral Research Fellow"

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

About Takeda

Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we're a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.

In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you'll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that's earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.

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.

Qualifications

• 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

Applicants should submit the following application materials by the priority deadline of October 31, 2025:

1. Curriculum vitae (CV), uploaded
2. Unofficial PharmD transcripts, uploaded
3. Cover letter, uploaded

Three formal letters of recommendation (LORs) should be sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 21, 2025. LOR writers must include the candidate's name and the fellowship program(s) in the subject line (e.g., Smith, John - Alnylam, GSK).

Address cover letter and letters of recommendation to: J. Andrew Orr-Skirvin, PharmD, BCOP, Clinical Professor, Department of Pharmacy & Health Systems Sciences Pharmaceutical Industry Fellowship Program Director, 360 Huntington Ave, 140 The Fenway R218 Boston, MA 02115.

Northeastern University considers factors such as candidate work experience, education and skills when extending an offer. Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement- as well as commuting & transportation. Visit https://hr.northeastern.edu/benefits/ for more information. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.

Expected Hiring Range: $59,425.00 - $83,935.00