About the Opportunity

About Takeda Pharmaceutical Company: 

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com .

Responsibilities:

Plasma -derived therapies  are critical, life-saving medicines that thousands of people with rare and complex diseases rely on every day around the world. The Plasma Derived Therapies Business Unit within Takeda focuses on reimagining plasma and going beyond incremental improvements to find a wide range of innovative and sustainable solutions to better serve patients. Our expertise, capabilities, and scale uniquely position us to transform plasma across our entire end-to-end operations and make a positive impact on people’s lives.

The Global Regulatory Affairs two-year fellowship is designed to provide post-doctoral graduates with an in-depth understanding of regulatory affairs and the drug development process through rotations within global regulatory strategy, labeling, and Chemistry, Manufacturing, and Control functions.

In each rotation, fellows will receive mentorship, guidance, and have opportunity to work with staff across various geographies and learn to navigate the complex dynamics and team environment at a truly global pharmaceutical company.

Fellowship Objectives

• Develop regulatory strategy by using and interpreting regulations and guidelines
• Provide support to the life-cycle management activities pre- and post-approval for plasma-derived therapies, and gain an understanding of the principles of agency review processes
• Gain an understanding of early and late phase clinical development and gain expertise in the requirements of regulatory submissions to global health authorities
• Understand the various facets of global regulatory affairs, including labeling, regulatory intelligence and strategy, and chemistry manufacturing and controls (CMC)
• Participate in departmental initiatives for process improvements
• Strategically guide product labeling across entire product lifecycle

The fellows will primarily work at Takeda’s office in Cambridge, Massachusetts. Northeastern University responsibilities will be carried out on the Northeastern Boston campus. 

Qualifications:

Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts OR Doctor of Philosophy degree in a biological or physical science. 

Excellent oral and written communication, time management, and leadership skills, ability to work independently and take initiative on a variety of projects at the industry site and Northeastern.

Additional Information:

Applicants should submit the following APPLICATION MATERIALS by the priority deadline of November 1st , 2023:

• Curriculum vitae (CV), uploaded
• Unofficial PharmD or PhD transcripts, uploaded
• Cover letter, uploaded

Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 29th, 2021. LOR writers should include the candidate’s name and fellowship program(s) in the subject line (e.g. Smith, John – Alnylam, GSK).

Address cover letter and three LORs to:

J. Andrew Orr-Skirvin, PharmD, BCOP

Clinical Professor, School of Pharmacy

Chair, Department of Pharmacy & Health System Sciences

Director of Pharmaceutical Industry Fellowship Program

360 Huntington Ave, 140TF R218

Boston, MA 02115

Position Type

Research

Additional Information

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.  

Northeastern University is an equal opportunity employer, seeking to recruit and support a broadly diverse community of faculty and staff.  Northeastern values and celebrates diversity in all its forms and strives to foster an inclusive culture built on respect that affirms inter-group relations and builds cohesion. 

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.

To learn more about Northeastern University’s commitment and support of diversity and inclusion, please see www.northeastern.edu/diversity .