Global Regulatory Affairs Fellowship

Empowering Our People to Shine

TAKEDA PHARMACEUTICALS & PURDUE UNIVERSITY

ABOUT TAKEDAFounded in 1781 and headquartered in Osaka, Japan, Takeda is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas; specialty cardiovascular diseases; and late-stage candidates for vaccines. For more information see www.takeda.com.

MISSION

Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine.

Takeda – Purdue GRA Fellowship Takeda Pharmaceuticals and Purdue University are offering a two-year Global Regulatory Affairs (GRA) Fellowship. The majority of the fellow’s time will be spent at Takeda in Cambridge, MA. The fellow will be an employee of Purdue University in West Lafayette, IN.

The Takeda – Purdue GRA Fellowship will provide a Doctor of Pharmacy (PharmD) graduate with the opportunity to gain specialized, hands-on training and experience in Global Regulatory Affairs. The fellowship is designed to prepare and develop the PharmD graduate for a career in regulatory strategy and drug development. In addition to bolstering a scientific link between Takeda and Purdue University, the fellowship aims to enhance the regulatory strategy activities at Takeda, with a goal to eventually serve and improve the drug development process across the industry.

Takeda PharmaceuticalsAt Takeda, the fellow will receive mentorship and individual guidance from the Global Regulatory Affairs Strategy team and will collaborate with cross-functional project teams, as well as Global Health Authorities. Additionally, the fellow will acquire a better understanding of the global drug development process through participation in various activities in the United States, the European Union, Japan and emerging markets.

GLOBAL REGULATORY AFFAIRS (GRA) AT TAKEDA• Serves as primary liaison between Takeda and Global Health Authorities• Provides regulatory intelligence necessary to generate and present information to meet

the needs of key stakeholders including Global Health Authorities, patients, purchasers and prescribers

• Provides regulatory strategic input required to expedite drug development, filing, and global regulatory approval of new drug or biologic products

• Collaborates with cross-functional teams to provide regulatory strategy to optimally design and implement successful drug development strategies

• Leads the development, submission, and maintenance of Investigational New Drugs (INDs), New Drug Applications (NDAs), Clinical Trial Applications (CTAs), and Marketing Authorization Applications (MAAs)

• Ensures compliance with global regulations and supports the interpretation of worldwide health authority requirements

Purdue University College of PharmacyAs an Adjunct Clinical Assistant Professor at Purdue, the fellow may have the opportunity to: • Develop, coordinate, and provide lectures for didactic pharmacy courses • Co-precept pharmacy students on advanced experiential rotations • Participate in professional development seminars with other fellows and residents from

Purdue and/or Takeda-affiliated programs • Create and lead university outreach activities to promote the fellowship program • Lead future Takeda – Purdue fellowship recruitment activities

GRA Fellowship DetailsELIGIBILITYThe fellow will be selected on a nationally competitive basis. To be eligible, candidates must be graduates of an Accreditation Council for Pharmacy Education (ACPE) accredited Doctor of Pharmacy Program before the fellowship begins in July.

Participation in the American Society of Health-Systems Pharmacist (ASHP) Midyear Clinical Meeting Personnel Placement Services (PPS) is strongly encouraged, but not required. The candidate must be eligible to work in the United States, as Purdue and Takeda will not provide sponsorship to foreign students.

BENEFITSThe fellow will receive a competitive stipend and benefits package, including comprehensive health and dental insurance. Attendance at one or more professional meetings, conferences or workshops will be sponsored by the fellowship.

CERTIFICATE OF COMPLETIONPurdue University and Takeda will award a professional certificate upon successful completion of the fellowship.

The fellowship candidate should:• Be passionate about a career in the pharmaceutical industry• Possess excellent oral and written communication skills• Demonstrate strong leadership qualities and effective interpersonal skills

Application Requirements:• Curriculum Vitae• Letter of Intent• Official college of pharmacy transcript• Three letters of recommendation

Global Regulatory Affairs Fellowship

As a pharmacist, I have the opportunity to bring a unique perspective to cross-functional global development teams. The talented individuals at Takeda and Purdue have facilitated my professional development, which will serve as an excellent foundation for a successful and rewarding career in the pharmaceutical industry.

Lance Kruger, PharmD, RPh2016-2018 Fellow, Global Regulatory Affairs Development – Gastroenterology Purdue University College of Pharmacy

As the inaugural fellow in Boston, I am grateful for the opportunity to join cross-functional teams and participate in global regulatory strategy and drug development. My dedicated mentors at Takeda and Purdue continuously support and guide me as I develop professionally as a fellow and future regulatory strategist. I believe this fellowship will serve as a strong foundation upon which I may build a successful and rewarding career in the pharmaceutical industry and academia.

Monica Pham, PharmD 2017-2019 Fellow, Global Regulatory Affairs Development – NeuroscienceTexas A&M College of Pharmacy

It was an honor to be the inaugural fellow of this program, and I am grateful for the opportunity it provided to transition to a full-time role at Takeda. In the ever-changing and complex field of regulatory strategy, this fellowship jumpstarted my career by providing valuable experiences in developing and executing regulatory strategies to bring innovative medicine to patients.

Yijia Luo, PharmD, RPh Senior Associate, Global Regulatory Affairs Development – Neuroscience at Takeda Pharmaceuticals

As a top 10 pharmacy program, Purdue University College of Pharmacy has a strong reputation for training elite pharmacy leaders. The fellow will have the opportunity to contribute to the didactic instruction and experiential learning of student pharmacists, as well as interact with world-class pharmacy faculty and researchers.

Amy Heck Sheehan, PharmDAssociate Professor of Pharmacy PracticePurdue University College of Pharmacy

PAST FELLOW

PURDUE SPONSOR

TAKEDA SPONSORS

CURRENT FELLOWS

Our Regulatory Affairs team provides creative regulatory strategies that enable Takeda to provide meaningful medicines to patients. We are committed to developing and maintaining the highest level of regulatory expertise. As a pharmacist with 20 years of experience in regulatory affairs, I know that pharmacists are well positioned to excel in this exciting and rewarding profession.

Tom Harris, RPhSenior Vice President, Head of Global Regulatory Affairs

Regulatory Affairs touches every part of the Takeda organization throughout the development of new medicines. As a member of a Global Regulatory Team, the fellow will assist in creating a global regulatory strategy for a compound and participate in the compound’s development.

Jonathon Parker, RPh, MS, PhDVice President, Global Regulatory AffairsHead, Global Regulatory Affairs Development – NeuroscienceHead, Global Regulatory Intelligence and PolicyExecutive Sponsor, Takeda – Purdue GRA Fellowship

As a former postdoctoral fellow, I believe that the Takeda – Purdue fellowship provides an ideal combination of focused training, dedicated mentorship and real-world experience for a candidate interested in pursuing a successful career in Global Regulatory Affairs.

Aansh Jarmarwala, PharmD, RACSenior Associate, Global Regulatory Affairs – Marketed ProductsFellowship Coordinator, Takeda – Purdue GRA Fellowship

Regulatory Affairs play a critical role in the development of a medicine for patients having involvement in all stages of development. As a mentor for one of the current regulatory fellows, I have seen this fellowship offer a great opportunity to learn about drug development, Global Regulatory Affairs, and the pharmaceutical industry.

Kim Lickteig, PhD Associate Director, Global Regulatory Affairs Development – Gastroenterology

A career in Regulatory Affairs provides an opportunity for tremendous impact on public health, and Takeda is committed to giving Purdue Regulatory Affairs fellows not only a window into this role, but active training in this exciting, challenging, and important field.

Adam Wasserman, PhDDirector, Global Regulatory Affairs Development – Neuroscience

Please send all correspondence to:Aansh Jarmarwala, PharmD, RACTakeda Pharmaceuticals U.S.A., Inc.One Takeda ParkwayDeerfield, IL 60015Email: GRAFellowship@takeda.com