Manager Management

AllyYoungmi Lee

***-** ***** ******** ******, Apt 9A, Flushing, NY 11355

Cell: 917-***-****

Email: **************@*******.***

Career Objective: I am most interested in clinical development, business development (project/product management/market access) and (global) regulatory affairs about regulations and market environments. I think my wide knowledge would help develop balanced and market-focused clinical development which leads to successful launch and sales of products.

Summary of skills:

• Possess more than eight years of professional experience in the pharmaceutical industry

• Excellent management skills and ability to handle multiple tasks efficiently

• Familiar with business environments as well as pharmaceutical laws/regulations

• Attention to details with good negotiation skills

• Strong project coordination and business analytical skills

• Excellent written and verbal communication skills

• Able to perform tasks cooperatively in a team environment as well as independently

Technical skills:

Familiar with computer applications like Microsoft Word/Excel/PowerPoint and Internet Explorer as well as internal SOP programs (e.g. CTD, NDA-related programs)

Professional Experience:

Organization: Pharmeng/Pfizer

Singapore, Singapore

Duration: May 2011 – Dec 2011

Designation: Regional Regulatory Manager (APAC region)

- Coordinate and maintain product certificates with other regions and responding to questions raised by Board of Health resulting from regulatory submissions in the region

- Manage regulatory affairs and associated regulatory documents to support lifecycle in the region (e.g. new indication application due to phase IV studies)

- Update CTD (CMC/clinical modules) sessions according to new regulations on projects

- Support the regional regulatory CMC conformance and GCMC products for regulatory submissions in the region

- Facilitate standardization and process optimization through data collection and interpretation, problem solving and consensus building

- Interface with multiple levels and business units in manufacturing sites, clinical departments, country offices to provide support and assistance of regulatory activities

Organization: Freelancer Consultant

South Korea

Duration: May 2009 – April 2011

Designation: Consultant (Independent representative)

• Business development/market launch, product licensing, regulatory affairs (approval/registration)

• Market/scientific research, pharmaceutical issues reviewing/reporting

Organization: PharmaKo Inc. (Pharmaceutical Consulting Company)

Seoul, South Korea

Duration: April 2007 to April 2009

Designation: President

1)Licensing consulting for contracts in importing/exporting pharmaceuticals

- Confidentiality, MOU and licensing contracts

- Importing/Exporting consulting (ex. consulting with int'l/domestic pharmaceutical companies, Importing/Exporting-related research and statistics)

- Distribution consulting (ex. consulting with int'l/domestic distributors, Distribution-related research and statistics)

- Patent-related consulting (ex. Expired products commercialization consulting)

2) Preclinical/Clinical trials outsourcing (ex. Overseas CRO consulting)

- Clinical trials collaboration/outsourcing consulting (ex. Clinical trials participation projects)

- Compliance with relevant regulations (IND/NDA) for clinical and preclinical trials

- Clinical development plan and SOP development

- Collection/Analysis of clinical-relevant regulations and policies

- Budgeting/Financial funding/government support for (pre-) clinical development

3) Approval/Registration-related consulting (ex. Domestic market feasibility studies based on Korean regulations)

- Regulatory affairs outsourcing (ex. Approval application outsourcing consulting)

- Regulatory affairs consulting

- Product approval/registration process

- Coordinate with business development plan and market launch

4) General consulting for pharmaceutical business structure and management

- Pharmaceutical general consulting (ex. Projects analysis and planning for clients)

- Business Structure consulting (ex. Merger between int'l/domestic companies)

- Business management consulting (ex. Domestic branch opening consulting)

Organization: Pharmaceutical Policy Dept. (Korean FDA under this dept.), Ministry of Health and Welfare

Seoul, South Korea

Duration: November 2003 to April 2007

Designation: Asst. Manager

1) Pharmaceutical-related policy establishment and regulations enactment/revision (medicines/medical devices/cosmetics)

- Review pharmaceutical issues (ex. Pharmaceutical manufacturing and sales separation)

- Prepare articles drafts and consensus meetings

- Prepare final articles and its legal procedures proceeding

2) Pharmaceutical distribution system management

- Modernize pharmaceutical transactions (ex. Studies on electronic business transaction system introduction)

- Prepare distribution-related regulations enactment/revision (ex. revision about the collection intervals and contents of pharmaceutical information)

- Manage drug price biding, distribution and process for clinical purposes

- Establish pharmaceutical information center (ex. regular expert meetings and outsourcing studies to get opinions and ideas on the pharmaceutical information center)

- Modernize distribution system (ex. collective distribution system introduction)

3) Public relations and guidance of pharmaceuticals

- Prepare for publication of new pharmaceutical policies and dealing with media/Korean FDA

- Contribute to annual guidance from the Ministry of Health and Welfare

4) Pharmaceutical-related associations and organizations management

- Manage associations and organization such as Pharmaceutical manufacturer association, Pharmacist association and Hospital pharmacist association

Organization: Regulatory Affairs Dept., SCHWARZ Pharma Headquarter Monheim, Germany

Duration: September 2002 to March 2003

Designation: Internship

• PUSR review, scientific review of insert papers

• Review clinical trials project managing and application materials

• Manage Korean pharmaceutical partners

• Translate Korean regulations and scientific articles

Educational Qualifications:

MS degree in Pharmaceutical Medicine (Medical school), Essen-Duesburg University (formerly Witten/Herdecke University) in Essen, Germany, 2001-2003

- Major courses: Health system & Pharmaceutical industry, Project management, Data management, Drug discovery & development, Toxicology, Biostatistics, Clinical pharmacology/Pharmacokinetics, Clinical Trials (I, II), Managing clinical trials, Health economics, Drug safety, PMS, Regulatory affairs, Marketing & sales, Biotechnology, Pharmaceutical-related case studies

- Thesis: Analysis and comparison of European and Korean pharmaceutical industries - differences within the drug development process and the MAA procedure between South Korea and the European Union

BA degree in Pharmacy (Pharmacy school) from Pusan National University in Pusan, Korea, 1996-2000

- Major courses: Biochemistry, Toxicology, Pathology, Physiology, Psychology, Mathematics, Inorganic pharmaceutical chemistry, Organic chemistry, Physical pharmacy, Pharmacognosy, Microbiology, Gross anatomy, Pharmaceutical qualitative analysis, Chemical engineering, Radiopharmaceuticals, Hygienic pharmacy, Pharmacy administration, Pharmaceutical botany, Pharmacology, Pharmaceutics, Pharmacopoeia, Pharmaceutical law, etc.

License:

Pharmacist licensure, Pusan University in 2000

Languages:

Excellent English and Korean, middle level of German (good at reading)

Honors/Publications:

Honor from the Minister of Health for work on Medicines Supply and Control Manual under National Crisis

Co-translating/publishing of German Pharmaceutical Law (AMG) into Korean

Translating of many pharmaceutical articles, dissertations and regulatory documents

Personal interests:

Cooking, hiking, movies, photography and painting

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