Regulatory Affairs, Medical Device, Pharmaceutical, Biotechnology

POOJA ARORA

**************@*****.*** 650-***-**** Santa Clara, CA 95054

EDUCATION

Candidate for MS in Regulatory Affairs for Drugs, Biologics and Medical Devices, GPA 3.95/4 Class of 2017

Northeastern University, Boston, MA

Courses: New Drug Development, Medical Device Development, Biologics Development, Human Experimentation (Clinical Trial Fundamentals), Strategic Planning and Project Management, Global Biotechnology Product Registration: E.U., U.S. Product Regulation, Canadian Asian and Latin American Regulatory Affairs, Clinical Trial Design Optimization and Problem Solving

MS in Biomedical Sciences, GPA 3.7/4 May 2012

Northeastern University, Boston, MA

Bachelors in Pharmaceutical Healthcare, GPA 3.97/4 May 2010

CU Shah College of Pharmacy-Mumbai University, Mumbai, India

ACADEMIC PROJECTS

• Submitted FDA Approval Package for approved statin drug, Lipitor

• Drafted a mock regulatory development plan for approved Type 2 diabetes drug, Invokana

• Prepared a mock BLA for approved anti-rheumatic biologic, Actemra

• Submitted a mock End-of-Phase II (EOP2) Meeting Request Letter for approved anti-rheumatic biologic, Actemra

• Designed a Biosimilar Development Plan for a biosimilar to a US-licensed reference product, Actemra

• Designed and developed a regulatory strategy and submission plan for Class II medical device

• Submitted a Mock 510(k) Filing for original and modified Class II Medical Devices

• Prepared a Letter to File (LTF) documentation: Regulatory Strategy for modifications to Class II Medical device

• Drafted and submitted a Business Case, Stakeholder Register, Risk Register and Project Management Plan (including plans for Change Management, Risk Management, Quality Management and Scope Management) for innovative combination product

SKILLS

Regulatory

• Complete scientific and regulatory understanding of drugs, generics, medical devices (Class I, II and III devices), IVDs, biologics, biosimilars and combination products

• Sound technical knowledge of and submissions including IND, NDA, ANDA, CTA, FDA 510(k), PMA, IDE, BLA, Biosimilars, Informed Consent, CE technical files, Design dossiers and Master Product Files

• Solid understanding of 21 CFR, ICH guidelines, QSR (21CFR 820), cGMP, cGLP, GCP, CAPA, eCTD submissions, STED submissions, FMEA, CFGs, MDD 93/42/EEC, IVDD 98/79/EC, MEDDEV, ISO 13485, ISO 14971, quality assurance, quality control and compliance

• Well versed with US and EU regulations, Canadian (CMDR) and Latin American (LATAM) regulations, GHTF, Risk Management, Post Market Surveillance, Medical Device Reporting (MDR), Labeling requirements (SPC and PIL) and Due Diligence specifications

Technical

Experienced with Windows, Mac and MS Office (Word, Excel, PowerPoint, Project, Outlook and Access)

WORK EXPERIENCE

Fullife Healthcare Pvt Ltd, Novelty Pharma GDD SA, Mumbai-Switzerland July’13 – Dec’14

Sr. Associate, Business Consulting and Market Development for International Clients

• Spearheaded expansion and B2B development initiatives in international markets of LATAM, CIS, SAARC, ASEAN, MENA, AFRICA and EUROPE as also B2C in domestic markets for a portfolio of products

• Identified the most suitable products or alternatives for a client or territory based on regulatory requirements, value analysis and surveys and client demands producing 5 times target number of qualified leads

• Designed solutions for clients to troubleshoot issues related to validation, compliance, regulatory approvals and documentation

• Contributed to generating $2 million revenue by estimating market size and formulating the selling proposition

• Negotiated business, prices, terms and agreements based on profit margin, volumes, competitive pricing and other specifications

• Identified threats and challenges to accurately conduct market trend evaluations, sales forecasting and segment strategies

• Developed technical/non-technical marketing collateral, digital media marketing presentations and website content

• Led cross-functional teams to implement and maintain strategic and operational plans

• Engaged in new product development including concept generation, business and technical analysis and new product pricing

• Identified potential opportunities, threats and challenges to accurately forecast the company budget

• Interpreted data on price, yield, stability, future investment-risk trends, economic influences, and other factors affecting business

Ipsen Biomeasure, Marlborough, MA Aug’12 – May’13

Research Associate, Quality Control and Validation

Audited process validation and periodic revalidation in compliance with cGxP guidelines

Documented SOPs and process development lifecycle

Performed data analysis and interpretation as well as assisted in regulatory filings and investigational reports

Involved in the purification and characterization of complex proteins using AKTA chromatography and other standard techniques

Enumeral Biomedical Inc., Cambridge, MA Oct’11 – Apr’12

Research Associate

Engaged in developing therapeutics through functional assaying of monoclonal antibodies and recombinant proteins

Performed immunoassays and molecular diagnostic assays such as PCR and RT-PCR for establishing DNA and RNA expressions

Executed ELISA for determining potency of the drug substance

Involved in cell culturing using human mammalian cells such as CHO and ARH77

Worked on micro engraving technique for antigen-specific antibodies, cytometry for content analysis and Genepix microarrays

Biogen, Cambridge, MA Jun’11 – Sept’11

Research Associate Intern, Product Development

Examined sensitivity of different components in multiple therapeutic proteins using higher throughput platform models

Performed protein analysis using High Performance Liquid Chromatography (HPLC) and Size Exclusion Chromatography (SEC)

Implemented assay development in protein formulations using analytical techniques such as Plate Reading, UV-Vis Spectroscopy, Micro Flow Imaging, Dynamic Light Scattering for particle size analysis

Performed Quality Control and Sterility testing diagnostic assays for process samples

AFFILIATIONS

Member of Regulatory Affairs Professionals Society (RAPS) Aug’16 - present

Member of Indian Pharmaceutical Association 2006 - present

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