Regulatory Affairs, Associate Director

Amber Ying Zhu

** ********* ***., ******, ** ****0

Phone: 732-***-****

E-Mail: **********@*****.***

PROFESSIONAL PROFILE

Motivated, action-oriented and results focused pharmaceutical/biotech professional with over 7-years of industry

regulatory experiences in various therapeutic areas of stem cell therapy, oncology, neuroscience, respiratory, infectious

diseases, metabolic disorder and women’s health. Demonstrates strong interpersonal, written, oral, communication,

strategy planning/execution and leadership skills. Familiar with team based dynamic work environment. Soundly

understands scientific principles and computer literate.

RELEVANT EXPERIENCE

Associate Director – Regulatory Affairs, Stem Cell Therapy, NeoStem Inc.

• Develop and implement global regulatory strategy to work with regulatory agencies worldwide, such as FDA,

Health Canada, PMDA, and EMA, to assure compliance with governmental regulations in all aspects of product

development and approval of filings for stem cell therapies.

• Drive identification, planning, execution of activities in support of regulatory filings. Provide regulatory

leadership and submission oversight to cross-functional areas, such as manufacturing, preclinical, clinical and

project management, to ensure the timely submission of high quality regulatory documents including BBIND,

CTA, BBIND/CTA amendments, Orphan Drug Application, Agency Meeting Briefing Packages, Agency

Responses and other documents required by regulatory agencies worldwide.

• Work closely with Project Management on schedules, document delivery, program risk and develop mitigating

strategies.

• Monitor global regulatory requirements, develops SOPs in support of Regulatory compliance. Evaluate and

establish processes to ensure submission publishing capabilities and document delivery in CTD and eCTD

formats.

• Collaborate with external CROs on regulatory issues in support of the cell therapy programs development.

Sr. Regulatory Submission Manager – Global Regulatory Affairs, Merck Sharp & Dohme Corp.

• Manage projects independently and lead cross function team. Served as single point of contact of Regulatory

Affairs and worked closely with the various stakeholders to drive the identification, planning, execution, and

tracking of regulatory strategy and submission activities that deliver high quality regulatory submissions at any

level of complexity for approval.

• Author, coordinate and facilitate major regulatory submissions: Investigational New Drug Application (INDs),

New Drug Application (NDAs), Clinical Trial Applications (CTAs), Orphan Drug Applications and International

Marketing Applications (IMAs) in Common Technical Document (CTD) and Electronic Common Technical

Document (eCTD) format.

• File NDA (US) in December of 2012 and WMA (Canada) in January of 2013 for Bridion (Sugammadex

Sodium Injection). Manage and maintain the marketed products life cycle regulatory requirement, including

license maintenance, post-approval commitments/requirements, post-marketing safety revision (labeling and

efficacy), and product claim support for US and global submissions. Such as SAPHRIS® (Asenapine)

Sublingual Tablets.

• Take leadership role in training and supervising 2 new hired regulatory associates by overseeing their everyday

submission works and cross function team meetings.

Sr. Regulatory Coordinator – Worldwide Regulatory Affairs, Merck Sharp & Dohme Corp.

• Author, coordinate, and approve United States FDA submissions for both IND and NDA filings in Electronic

Common Technical Document (eCTD) format.

• Guide and contribute to the preparation of global regulatory dossiers for submission of CTAs and IMAs.

• Drive successful execution of regulatory strategy for complex US and International pharmaceutical products,

including both new product development ( Oncology Orphan Drug Application in US and EU ) and existing

marketing applications (SINGULAIR™).

• Represent and lead the regulatory function on assigned cross-functional project teams to ensure timely regulatory

submissions, such as various types of IND/CSA amendments; NDA CBEs (CMC or labeling supplements) and

PAS, annual reports, Agency Background Packages and Agency Responses (global).

• Monitor applicable regulatory requirements and ensure compliance.

• Execute regulatory strategy by ensuring that project teams and business objectives and deliverables are aligned.

• Identify compliance risks and appropriately escalate issues when necessary.

• Formulate, co-author, and implement guidance documents for departmental use and implementation.

• Mentor employees new to the regulatory field, or new to working with the FDA.

• Attend relevant internal or external courses to expand regulatory knowledge and professional development skills.

Research Biologist – Merck Research Laboratories

• Liaise effectively with the department of Laboratory Animal Research to accomplish all the essential surgeries

and to supervise post surgery maintenances for hypertension studies. Showcase leadership skills successfully by

managing and coordinating standard operation procedures to facilitate development of new hypertension

programs.

• Participate actively in a cross-functional committee as a Control substance Monitor to ensure the compliance of

our department with MRL polices.

• Communicate effectively with scientists within MRL to support varies hypertension related projects to achieve

our goal(s). Tasks included collecting and providing treated biological samples, coordinating study take down,

and optimizing in vitro functional assays.

• Negotiate service contract cost for several clinical diagnostic instruments in the lab, which not only acquired

reasonable price packages, but also received great maintenance services.

• Participate diligently in establishing in-house mice models to support the Niacin Receptor Agonist Project.

Assignments involved short-term and long-term mice POP studies, genotyping knockout mice, measuring mice

lipid levels, and validating data through biochemical assay kits, FPLC and Roboflan.

EMPLOYMENT HISTORY

NeoStem Inc., New York February, 2014- Present

Associate Director of Regulatory Affairs

• Develop US and international regulatory strategies and responsible for regulatory filings for human stem cell

therapy products of NeoStem globally. Serve as the primary interface for regulatory agencies on assigned

projects.

• Assist to build an appropriately staffed team to seamlessly manage a demanding and growing portfolio.

• Represent regulatory affairs as single point of contact for cross-functional team.

Merck Sharp & Dohme Corp., Rahway, NJ 2011-2013

Regulatory Submission Manager

• Represent the department as Global Dossier Management Subject Matter Expert (SME) that brings overall

efficiency to the regulatory organization to develop best practices and address immediate issues in a changing

environment.

• Provide excellent communication in support of our department and external stakeholders in all forms. Such as

represent the department as a key member of Experimental Medicine Team to facilitated domestic and

international regulatory submissions of clinical study applications. This work supports the commitment of

restoring Merck's place as the industry leader in creating innovative ways to establish Proof Of Concept for new

mechanisms by exploring clinical models and novel biomarkers that could yield better, faster, and more cost

effective ways to prioritize preclinical drug candidates with the highest likelihood of becoming new and valuable

medicines.

• Provide informal training sessions to other new submission development leads of neuroscience and ophthalmic

franchise who are not familiarized with the new job roles.

Merck Sharp & Dohme Corp., Rahway, NJ 2007-2011

Senior Regulatory Coordinator

• Mentor and offer guidance to colleagues regarding global regulatory Agency interactions and execution of

regulatory strategy.

• Provide representation and leadership on committees to standardize internal processes and ensure departmental

procedures are in line with business need and strategy.

• Track and coordinate the execution of regulatory strategy and advise team members of global regulatory

submission requirements by interpreting and conveying guidelines to ensure regulatory compliance.

• Coordinate the assembly and submission of high quality agency communications, reports, or other documentation

to support assigned developmental products.

Merck & Co., Inc., Rahway, NJ 2004-2007

Research Biologist,

• Characterized and developed novel targets for the genetic regulation of hypertension.

• Characterized and published novel insights into the genetic regulation of serum lipid levels.

• Research Associate IV, Regeneron Pharmaceutical, Tarrytown, NY

• Purified successfully in-house hyridoma monoclonal antibody to support the Velocigen project, and performed

various types of ELISA assay for characterization and validation

• Research Associate Scientist II, Bayer Pharmaceutical. West Haven, CT 2002-2004

• Participated actively in the Functional Assay Committee to perform proliferation assays in different panels of

cancer cells line to achieve high-through-put screenings.

• Characterized and published novel insights into the genetic regulation of cancer research.

Regeneron Pharmaceutical. Tarrytown, NY June, 2004 - December, 2004

Research Associate Scientist IV

• Purified successfully in-house hyridoma monoclonal antibody to support the Velocigen project, and performed

various types of ELISA assay for characterization and validation.

Bayer Pharmaceutical. West Haven, CT 1999-2004

Research Associate Scientist II

• Participated actively in the Functional Assay Committee to perform proliferation assays in different panels of

cancer cells line to achieve high-through-put screenings.

• Characterized and published novel insights into the genetic regulation of cancer and osteoporosis research.

• Recipient of the Special Recognition Award

Yale University, School of Medicine New Haven, CT 1997-1999

Research Assistant II

• Led the research of the role of insulin in the abnormal glucagon secretory response to hypoglycemia in Type I

Diabetes, which was the focus of the master thesis.

• Assisted in NMR studies to observe non-diabetic rats brain function during acute hypoglycemia.

• Collaborated with colleagues to study different regions of brain ECF glucose level between diabetic and non-

diabetic rats during different stages of hypoglycemia.

EDUCATION

SOUTHERN CONNECTICUT STATE UNIVERSITY, New Haven, CT 2002, M.S., Biology

UNIVERSITY OF CONNECTICUT, Storrs, CT 1997, B.S., Molecular and Cell Biology

PUBLICATIONS

- Ren, N., Kaplan, R., Hernandez, M., Cheng, K., Jin, L., Taggart, Andy., Zhu, Amber Y., Gan, X., Wright, S., and

Cai, T. 2009. Phenolic acids suppress adipocyte lipolysis via activation of the nicotinic acid receptor GPR109A

(HM74a/PUMA-G). J Lipid Research. 50:908-914.

- Jiyi Fu, Ying Zhu, Xiuying Sun, William Lathrop, Patricia Conrad, Hong Shi, Andy Lyga, Brian Dixon and

Marie-Luise Blue. Functional Cross-Binding of Steroids to Receptors in Osteoblasts. Endocrine Society 83rd

Annual meeting

- Xiaoning Fan, Rory McCrimmon, Ying Zhu, Ralph J Jacob. Brain ECF glucose Concentrations in Non-Diabetic

Rats: No Effect of Functionally different Brain Regions. Diabetes: A Journal of the American Diabetes

Association. Volume 48

- Ralph J. Jacob, Xiaoning Fan, Ying Zhu, Rory McCrimmon, Robert S. Sherwin. Does Antecedent Recurrent

Hypoglycemia Alter Brain ECF Glucose Levels during acute Hypoglycemia in Diabetes? Diabetes: A Journal of

the American Diabetes Association. Volume 48

- Ralph. J. Jacob, Xiaoning Fan, Ying.Zhu, Fusun Toruner, Robert S. Sherwin. Brain ECF Glucopenia is More

Pronounced in Diabetic BB Rats during Mild Systemic Hypoglycemia. Diabetes: A Journal of The American

Diabetes Association. Volume 47: A37

SOFTWARE PROFICIENCIES

GraphPad Prism, HTML, Sigma Plot, Lotus Notes, Microsoft Office Suit, Microsoft Windows® 2010, Windows® XP,

Primer Express, Acrobat Adobe PhotoShop and PageMaker, Softmax, Net Meeting, Windows Messenger, Microsoft

Office Communicator, Reference Manager Professional Network and Documentum.

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