Mengxin Ma

Phone: 412-***-**** Email: ac6bba@r.postjobfree.com

*** ********* ***, *** **, Central Islip, NY 11788 Professional Summary:

• Highly collaborative and Regulatory focused individual with in depth analysis skills and experience in the pharmaceutical field with a strong chemistry background.

• Highly involved in product development and product registration, both domestic and international.

• Effective communication skills, detail orientated, and the ability to multi-task while thriving in a fast-paced, deadline-driven environment.

• Well informed of changes in regulatory legislation and guidelines. Professional Experience:

A&Z Pharmaceuticals, Inc. 07/2016 to Present

Regulatory Affairs Associate Hauppauge New York USA 11788

• Familiar with regulatory regulations as per FDA guidance, ICH guidelines, 21CFR and the China Food and Drug registration regulation.

• Perform regulatory research, concerning project feasibility in multiple markets, not limited to the US, China, UK, and Canada.

• Communicate with regulatory agency regarding pre-submission strategies, potential regulatory pathways, and compliance requirements.

• Review and approve submission documents; including R&D reports, MBR, process validation, method validation, and stability protocol and reports to ensure all discrepancies are identified and corrected, addressed concurrently, and assembled in accordance with established timelines.

• Prepare and review regulatory submissions; including preparation of CMC sections, such as ANDA in eCTD format, amendments, supplements and information request responses.

• Prepare DMF (Type II API) submission documents in CTD format for USFDA and China-FDA.

• Research and analyze prescription drug, OTC drug and dietary supplement product labeling components from all locations to ensure accuracy of the content, including bottle labels, cartons, packaging inserts, and medication guides.

• Create side-by-side comparisons of labels, cartons, outserts, medication guides and oversee Final Printed Labeling (FPL) for regulatory submissions.

• Contact raw material and packaging components vendors to obtain, review and evaluate the RA statements and relevant technical information during sourcing, to ensure the regulatory compliance of the raw material and packaging components with U.S. and international regulations.

• Review in-house SOP and Change Control documents.

• Prepare documents for FDA onsite inspection review. Invagen Pharmaceutical Inc. (Cipla Ltd.) 06/2015-06/2016 Quality Control Chemist Hauppauge New York USA 11788

• Analyzed raw materials, in-process and finished product and stability samples using modern quality control techniques in a cGMP/GLP environment.

• Performed Quality control activities by doing analytical tests to validate data and analyze results as per Current USP, BP, EP and JP.

• Assisting senior scientists in developing implementing and maintaining quality control system and activities. SKILLS

• Experience with various analytical instruments and spectral analyses.

• PLM (Product Lifestyle management).

• Proficient in Media software editing, Microsoft Word, Excel, Power Point, and Adobe Acrobat

• Languages:English (Professional working proficiency),Chinese (Native Speaker) EDUCATION

M.S Chemistry, Stony Brook University (Stony Brook, NY, USA ) 05/2016 B.S Chemistry, Southeast University (Nanjing, Jiangsu, China) 06/2014 Major: Chemistry

Minor: Economics and Management

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