Terry Chan37 Taft Lane 973 610 3372 Terrychan888@hotmail.comMorristownNJ 07960

Profile

26 years within the pharmaceutical industry working in Regulatory Affairs, Regulatory Compliance and in Analytical Chemistry.

Highly proficient self-motivated and experienced within Chemistry, Manufacturing and Controls and worked in the Upper Respiratory, Allergy, Pain, Gastrointestinal and Smoking Cessation therapeutic areas of a major OTC company. Experience in US, UK, Irish and European regulations. Now seeking a next challenging and rewarding opportunity to demonstrate abilities and make an effective contribution in a successful and focused team.

Employment History

Regulatory Affairs Manager – Chemistry, Manufacturing and Controls Regulatory Affairs Manager – McNeil Consumer Healthcare, PA – May 2009-Jan 2015

Senior Regulatory Affairs Associate - McNeil Consumer Healthcare, PA – Nov 2007-May 2009

Provide complete Regulatory Strategies based upon review of regulations, guidance documents, best practices, and review of CMC submissions

Provide CMC regulatory requirements and expectations for proposed changes and new products. Review change controls for analytical, manufacturing and packaging changes and provide regulatory

assessments. Author and review CMC sections of New Drug Applications, Prior Approval Supplements, Changes

Being Effected, and Annual Reports. Provide responses to Health Authority questions that arise during dossier review. Perform NDA/ANDA gap assessments from original NDA/ANDAs to current CMC filing to ensure all

changes were captured and filed, as appropriate. Review Research and Commercial Master Formula Records. Provide regulatory expertise in Committee meetings (Stability and Packaging Materials Evaluation) Manage CMC sections for an Orally Disintegrating product in an NDA application. Coordinate FDA

deficiency responses between cross-functional teams. Maintain DMFs for smoking cessation products and complete compilation and review of an IND

submission of a related product. Create a reference list of submissions to harmonize writing styles across different therapeutic areas

to increase submission efficiency.

Manufacturing Compliance Specialist – Pfizer Inc., Morris Plains, NJ - Sep 2001-Nov 2007

Coordinate and prepare documentation for post approval supplements for Consumer Healthcare products.

Coordinate the implementation strategy for post approval change management. Ensure the proper implementation and maintenance of regulatory requirements for Consumer

Healthcare products. Provide European regulatory advice as required. Review technical documents prepared for supporting changes or variations required by specific

National Health Authorities worldwide. Assist Pfizer Global Manufacturing Site Compliance Managers and Regulatory associates with

responses to questions from regulatory agencies.

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Provide information, data and documents to ensure compliance with registration requirements. Coordinate closure of gaps of products resulting from Site Compliance Assessments. Participate in the review and population of data for the Global Regulatory System database.

Manufacturing Compliance Specialist – Pfizer Inc., Paris, France - Apr 2001-Sep 2001

Prepare Site Compliance Assessment forms for the audit of products at Pfizer manufacturing sites. Participate in the testing of the forms with selected sites. Liaise with Global Regulatory Affairs to identify and confirm relevant markets.

Liaise with Global Distribution to identify audit priority markets by sales and volumes. Assisted in the compilation of the Site Compliance Assessment Manual.

Senior Registration Executive – Pfizer (Warner-Lambert, UK) - Oct 1996-Apr 2001

Registration Executive - Pfizer (Warner-Lambert, UK) - Mar 1995-Oct 1996

Prepare, review and submit new product licence applications e.g. simple and standard abridged in line with European guidelines and some experience in Mutual recognition applications.

Liaise with the European Regulatory Affairs group to identify filing strategy for possible Mutual Recognition candidates. Liaise with Regulatory Compliance Groups to obtain and review Chemical and Pharmaceutical documentation for new product licence applications, variations and renewals. Co-ordinate between the European regulatory affiliates and manufacturing sites to obtain Chemical and Pharmaceutical information resulting from assessment of new product applications.

Development Technologist - Warner Wellcome Consumer Healthcare, UK - Jun 1994–Mar 1995

Development and manufacture of pilot scale batches of new products. Set up stability trials for newly developed products. Develop and validate new methods of analysis. Write methods for Product Life and Release specifications. Trouble-shoot analytical instruments. Combine data in the form of a Part II dossier for submission to the Regulatory Affairs Department.

Technical Services Chemist - Parke, Davis & Company Limited, Warner Lambert, UK – June 1993-Jun 1994

Manufacture of pilot scale batches of product, assess new raw materials for existing products, draft technology transfer protocols and validation of production processes.

Senior Development Analyst - Parke, Davis & Company Limited, Warner Lambert, UK – Jun 1990-Jun 1993

Set up stability trials for new products. Analyse routine and non-routine samples by physical and chemical means. Develop and validate methods of new products. Write methods for Product Life Specifications for inclusion in the Chemistry, Manufacturing and Controls section of the submission dossier. Trouble-shoot analytical instruments i.e. (H.P.L.C., G.C.).

Quality Assurance Analyst - Parke, Davis & Company Limited, Warner Lambert, UK – Feb 1988-Jun 1990

Analyse products on Stability trials to provide supporting data for regulatory packages. (H.P.L.C., G.C. and A.A.S techniques used).

Routine analysis of active and excipient raw materials to the British and European Pharmacopoeia and In-House specifications.

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Computer Skills

Microsoft Office (Excel, Word, PowerPoint), Outlook, Documentum, DocuBridge

Education

University of Glamorgan, Pontypridd, UK BSc (Hons) Chemistry - 2:2

General Interests

Running Completed 7 Marathons

Cape May, NJ (2003) New York, NJ (2004, 2006, 2007, 2009) Jersey Shore, NJ (2008) Walt Disney World, FL (2015)

Traveling

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