• M.S in Drug Regulatory Affairs and 2+ years of experience in Pharmaceutical Industry across all Verticals with International Exposure
• Work experience in preparing, reviewing and assembling ANDA submissions and sending to FDA via gateway.
• Work experience on ANDA, DDMAC and Investigator Package publishing in eCTD format via regulatory software’s like gCTD, RAPID, CORE DOSSIER and eCTD Express.
• Experience in design, development and maintenance of various Data Analysis Projects.
• Work experience at managerial level in marketing and technical associate in QA/QC department for Pharmaceutical Industry.
• Successfully compiled and published Thesis project- “Burnout and Stress among Regulatory Affairs professionals”, which received good response and huge appreciation across all level.
• Good interpersonal skills adapt and learn new strategies and business lines rapidly.

PROFESSIONAL SKILLS

• Prepare, Review, Assemble, and Evaluate ANDA a submission using regulatory software’s and submit to FDA via gateway.
• Experience with compliance check, compiling and submitting submissions for DDMAC and Investigator Packages in eCTD format to FDA for entire product range.
• Submitted 2 ANDA, 150 DDMAC and 15 Investigational Packages Submissions to FDA.
• Involved in QC for 15 day IND safety report publishing.
• Knowledge of compiling IND/NDA/BLA in eCTD format and developing TPP, SPL, Labeling and Advertising.

Computer Skills

• Experience on regulatory software’s (gCTD, RAPID, CORE DOSSIER, eCTD Express) to compile submissions in eCTD format.
• Proficiency in MS-Office, ISI tool box 5.5 and 6.2, Acrobat 5, 7, 8, 9 and 10, Documentum, , SPSS-18 and Nvivo-8.

PROFESSIONAL EXPERIENCE

Nov 11 – Till Date Confidential Environment- ANDA Submissions
Skills: Prepare, Review, Assemble, and Evaluate ANDA submissions, amendments, supplements, and annual reports. Working on regulatory software’s (eCTD Express, ISI Publisher and Toolbox) to publish the documents in eCTD format and submit to FDA via electronic gateway.
Description:

• Preparing, reviewing, assembling and evaluating ANDA submissions to ensure document accuracy and completeness.
• Interpret FDA policies and guidance to ensure company compliance.
• Create CTD format template for ANDA Application and submit the ANDA in CTD/eCTD format to the FDA Agency.
• Interact with Research and Development, Quality Assurance/Quality Control (QA/QC) and production for gathering data and documentation for submission.
• Generate SOP’s as needed for Regulatory Affairs Group.
• Organize and maintains regulatory affairs department files

Jan 11-Nov 11 Confidential Environment- DDMAC and Investigator Packages Publishing
Skills: Compliance check for DDMAC and Investigator 1572 and CV’s, Working on regulatory software’s (gCTD, RAPID, CORE DOSSIER) to publish the documents in eCTD format and submit to FDA via secured gateway
Description:

• Preparing and reviewing submission (DDMAC and IP) documents for FDA submission.
• Ensuring documentation complies with regulations for FDA submissions.
• Ensuring submissions meet deadlines and mentoring regulatory associates, assisting them in the compilation of documentation for submissions.
• Assembling submission documents using eCTD format and using regulatory software in compiling eCTD submission.
• Responsible for performing effective management of submission planning and execution of plans to achieve aggressive timelines in support of commercial business.
• Compliance checked Compiled and submitted DDMAC applications, protocol amendments and Investigator packages to government agencies via regulatory software in eCTD format.
• Trained two regulatory associates who supports compliance check of DDMAC and Investigator packages submissions
• Worked with other project team members, including Program management, Quality Assurance, Compliance, Marketing and counterparts in company Regulatory Affairs.
• Obtained documents/information for regulatory submissions from various functional areas and checked for errors, missing information, legibility, translations, etc
• Maintained up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guidelines, and proactively provided guidance to the Regulatory staff as needed during assembly of regulatory submissions

May 09-Nov10 Project Assistant- Confidential Asthma Education and Counseling Program:

• Collect, Interpret and analyze quantitative and qualitative data using Nvivo-8 and SPSS 18 obtained from participants about their beliefs, knowledge and attitudes towards their diseases state.
• Played primary contact for the client and secondary contact for the investigator and provided effective communication among all the people involved in the project.
• Monitored the sites and ensured all the timelines for submissions are met.

May 06-Jan 08 Associate Sales Manager- Confidential

• Achieved target goal of $150,000-$200,000 a month.
• Visited 50 highly qualified doctors weekly to achieve goals of company.
• World Sales Effectiveness Training at GSK.

May05-Dec05 Intern- Confidential

• Worked in Manufacturing and learned to design and develop SOP’s for the product range.
• Rotated and worked in QA/QC departments to learn the applicable quality standards for assigned products.

Course Work

Drug and Regulatory Affairs, International Drug Regulatory Affairs (focus on EU and Canada), Regulatory Compliance and Enforcements, FDA-Regulation of OTC, Medical Devices and Cosmetics, Pharmaceutical Labeling Advertising and Promotion, Mechanics of Preparing IND and NDA and FDA meeting, American Pharmaceutical Industry, Research Methodology, Research and Thesis I, Research and Thesis II, Biostatistics, Seminar Social and Administrative Services, GMP and ICH-GCP guidelines.

Academic Projects

• Thesis Project: “An examination of Job Stress and its effects on Burnout, Job Satisfaction and Job Turnover Intentions amongst Regulatory Affairs Professionals in New Jersey”.
• Preparation of Investigational New Drug Application (IND) for Initiation of Phase 2 study in depression patients.

Employment History

• Confidential IL as Regulatory Affairs Associate from Nov-11 till date.
• Confidential MI as Regulatory Submission Publisher from Jan-11 to

Nov-11

• Confidential NY as Project Assistant from May-09 to Nov-10
• Confidential as Associate Manger from May-06 to Jan-08

Honors and Affiliations

• Graduate Assistant and Teaching Assistant at Confidential
• Recipient of Confidential
• Member of Confidential

Education

• Currently pursuing M.S. Business Administration
• M.S. Drug Regulatory Affairs
• B.S Pharmacy