Shilpa D.

Director of Regulatory Affairs

Role: Director, Regulatory Affairs at Partner Therapeutics
Location: Menlo Park, CA, US
LinkedIn followers: 500 followers

General Business & ManagementView LinkedIn profile

About Shilpa D.

Over 14 years of Regulatory filing experience working on projects at various stages. Primary liaison with the USFDA on various projects. Global experience working with MHRA, Health Canada. Post marketing/life cycle management. Drug Listing. REMS. ICH guidelines. eCTD publishing. Quick thinker. Fast learner. Strong interpersonal and communication skills. Ability to navigate multiple projects simultaneously and efficiently. Achieving success is fundamentally rooted in a dedication to consistent hard work!

Experience

Director, Regulatory Affairs
Partner Therapeutics
Apr 2025 — Present · Lexington, MA, US

Education

St. John's University
Masters, Industrial Pharmacy
Birla Institute of Technology and Science, Pilani
B.Pharm (Hons.), Pharmacy
2003 — 2007

Contact information

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Current company

Partner Therapeutics

Biotechnology Research · 190 employees · Founded 2017 · Lexington, Massachusetts, United States

WE'RE ALL IN FOR FIGHT AGAINST CANCER Partner Therapeutics is devoted to developing and commercializing cancer medicines and combination therapies that can make a meaningful difference in the lives of cancer patients. We are united in our passion for improving the treatment of cancer and our desire to make a meaningful contribution to outcomes. THE PATIENT IS NUMBER ONE We believe that being a cancer company begins and ends with the patient. We strive to support patient needs throughout their treatment journey to help them make the treatment choices that are right for them and their loved ones. FIGHTING CANCER IS TEAM SPORT We believe that cancer is a complex, dynamic disease that requires a multi-faceted, multi-disciplinary approach to tackle. We believe in teamwork at each stage of a therapy’s development, and seek to build teams of experts, both internally and externally, that cover the breadth and depth of the complex problem that is cancer. We work with leading companies and investigators to ensure that our products are tested in the best settings, and in combination with highest potential regimens to maximize benefit to patients and to advance the understanding of cancer treatment. We seek to engage all members of the cancer treatment team as well as thought-leading physicians and patient advocacy organizations to ensure that clear, complete and balanced information about our products is proactively communicated and readily available. We work to support the extraordinary dedication of the medical teams that represent the front lines in the war on cancer. OUTCOMES ARE OUR YARDSTICK We believe that innovation is not enough. In the challenging world of today’s healthcare climate, we strive to develop and assess our products based on the real-world impact they have in improving the quality and duration of our patients’ lives. We measure our success in the birthdays, anniversaries and other important life moments that our patients are able to enjoy.

partnertx.com

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About Shilpa D.

Experience

Director, Regulatory Affairs

Education

St. John's University

Birla Institute of Technology and Science, Pilani

Find verified contacts for anyone on LinkedIn