I am inspired by the intellect and collegiality of the people around me. We have a culture that promotes excellence, which is driven by a deep sense of purpose to impact global health.
Navdip Ghai
Principal Scientist, Regulatory Affairs-CMC
Lorem ipsum
Global Regulatory Affairs and Clinical Safety
Leveraging diverse expertise in measurement science to be partners in problem solving.
Driven by our dedication to product and patient safety.​​​​​​​
Driven by our dedication to product and patient safety.​​​​​​​
Our Global Regulatory Affairs & Clinical Safety (GRACS) team supports products from early pipeline development through divestiture or market withdrawal, in which duration could span 10 to 100+ years. We are dedicated to our purpose to optimize access to our medicines and vaccines through cutting-edge regulatory strategies and uncompromising commitments to patient safety, quality and compliance.
We are always striving for operational excellence. We cover a wide range of activities related to getting products on the market and keeping them on the market. Our aspiration is to lead the industry in regulatory and safety science through ingenuity, innovation and integration.
Work with people who innovate everyday.
Work with people who innovate everyday.
Growing up, I was taught that if something doesn't challenge you, it won't change you. With that in mind, I'm rarely afraid of a challenge. That means I know I'm going to have to put in the work for every success. Here, we put in the work, grow together, and along the way we support a purposeful purpose.
Chaundra Magwood
Director, Regulatory Affairs-CMC
I practiced as a neurosurgeon and cancer research scientist in an academia institute where I treated patients with brain tumor before joining the pharmaceutical industry. Fighting cancer has become one of my personal missions. It's an honor and a privilege being part of Merck oncology, a dedicated group of professionals with a common purpose.
Michael Liu
Distinguished Scientist, Drug Safety
I find myself surrounded by professional colleagues with extensive knowledge about patient safety. It is the right group of people who are uplifting, motivating and inspiring. Together we strive to have positive impact to the oncology patient population in need of innovative medicine. Putting the patient first and following the science to address significant unmet medical need is our purpose.
Jian Ye
Distinguished Scientist, Drug Safety
It is exciting to be part of an organization that is at the forefront of cancer research. We are making tangible contributions every day to bringing new, innovative, life-improving treatments to patients all over the world. I value the spirit of collaboration, scientific excellence and dedication to safeguarding patients’ health that is an integral part of Clinical Safety and Risk Management department.
Inna Pendrak
AVP, Drug Safety
Our organization
Our organization
We are a collective group of diverse functional areas focused on regulatory strategy, execution, and compliance for the three essential elements of every approved therapeutic: clinical efficacy, clinical safety, quality and chemistry and manufacturing and control.
Chemistry, Manufacturing & Controls (CMC)
CMC is responsible for developing the strategy, submission, and execution plans for the CMC sections of clinical trial applications, worldwide market applications, manufacturing enhancements and change controls in life-cycle management.
Global Clinical Safety & Pharmacovigilance (GCS&PV)
The GCS&PV function aims to improve public health by assuring the safe use of our products worldwide through proactive safety assessment, effective risk management and transparent risk communication.
Innovation, Quality & Strategic Execution (IQSE)
The IQSE organization provides operational and quality capabilities across the GRACS organization supporting global, regional and local operating models to provide central oversight for GRACS. IQSE is focused on innovative business approaches and leveraging state of the art information management tools to enable effective and efficient execution of our processes. The team leverages its diverse skill sets to identify challenges across the operations of the GRACS business and collaborations with the various functions to drive them to resolution.
Global Regulatory Policy (GRP)
Our GRP team works collaboratively with internal and external stakeholders to influence the policy environment set by global regulatory authorities and provides subject matter expertise on emerging issues and how we can influence policy outcomes.
Regulatory Affairs International (RAI)
Our RAI team helps provide new and compliant medical products, practices and solutions to the world.
Therapeutic Areas
Therapeutic Areas in GRACS are responsible for developing and implementing the global regulatory strategy for their assigned products.
Our Therapeutic Areas are organized into three groups:
Our Therapeutic Areas are organized into three groups:
• Vaccines & Infectious Diseases
• Oncology & in Vitro Diagnostics
• General Medicine & U.S. Subsidiary
• Oncology & in Vitro Diagnostics
• General Medicine & U.S. Subsidiary
