Hem Shah, Msra Email & Phone Number

New York City Metropolitan Area

1. Maintain data and files for future reference, including tracking lists for regulatory activities such as planned and completed submissions for IND’s and NDA’s, particularly in the event of an audit by a regulatory agency.2. Interact with Regulatory and Quality Assurance staff, and with other functional areas, to ensure planned activities are communicated and compliant with relevantregulations; review marketing, legal, and technical documentation (including case files and clinical… Show more 1. Maintain data and files for future reference, including tracking lists for regulatory activities such as planned and completed submissions for IND’s and NDA’s, particularly in the event of an audit by a regulatory agency.2. Interact with Regulatory and Quality Assurance staff, and with other functional areas, to ensure planned activities are communicated and compliant with relevantregulations; review marketing, legal, and technical documentation (including case files and clinical research reports) to assess compliance.3. Recommend courses of remediation to help achieve the necessary levels of compliance.4. Review and prepare outlines, summaries, and status reports for communication to RAQA and other functional areas.5. Write meeting minutes for RA-led meetings, internal or external.6. Work with vendors and/or contractors to coordinate submission.7. Act as a liaison between organization and state, local, federal, and international agencies to submit required forms and paperwork.8. Draft and prepare documents for submissions.9. Collaborate with other departments and contribute on planning global submissions.10. Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on thesubmission strategy.11. Review changes to existing products and SOPs to define the requirements for regulatory submissions.12. Perform other Regulatory Affairs duties as assigned including providing general management and research support. Show less

India

•Engaged in strategic decisions process for submitting clinical trial applications to multiple country authorities and coordinated local and back-office teams to meet the planned submission deadlines. •Successfully prepared and coordinated regulatory deliverables for pharmaceutical clinical trials in the US through close cooperation with internal and external teams, including Regulatory Authorities representative of the FDA. •Contributed to the teams 98% success rate of submissions… Show more •Engaged in strategic decisions process for submitting clinical trial applications to multiple country authorities and coordinated local and back-office teams to meet the planned submission deadlines. •Successfully prepared and coordinated regulatory deliverables for pharmaceutical clinical trials in the US through close cooperation with internal and external teams, including Regulatory Authorities representative of the FDA. •Contributed to the teams 98% success rate of submissions within the established deadlines through more than a hundred application packages for initial and maintenance Clinical Trails. Show less

Greater Boston

• Served as liaison between student body and administration by developing initiatives to voice student interest.• Introduced 4 SGA bills and other legislation for change on campus and introducing ideas of change and development.

Greater Boston Area

• Facilitated events and designed flyers for 20+ university projects such as International Student Orientation, CPT workshops.• Coordinated with 3 Directors of Immigration and International Services for expired VISA, SEVIS Check-In, OPT for students.• Developed a website with QR code for easy sign in access benefitting 1000+ students.

Boston, Massachusetts, United States

• Enhanced student life for MCPHS commuters by providing opportunities for students to meet and socialize.• Raised the voice of commuter and off-campus students.• Expressed the concerns and needs of off-campus students to the university.

Greater Boston

- Helped students generate business ideas and marketing strategies- Conducted student seminars on building interviewing skills and networks with employers via ppt.- Programmed activities for students on different roles in business and business ownership- Helped students to build connections with MCPHS Alumni owning Businesses in various fields

Ahmedabad Area, India

• Performed 3 IND submissions by collaborating with regulatory managers.• Built and maintained trackers for status of global regulatory submissions.• Reviewed 20+ CDSCO forms supported by regulatory managers.

Ankleshwar, India

- Learned and practiced financing, management, marketing and administration by being mentor by the manager of thedepartment- Researched national approach to the ongoing recession in India to increase sales and outreach of the company- Studied marketing strategies on how the companies work and sell their products during the economy’s downtime

Master'S Degree, Fda And Regulatory Affairs

Bachelor'S Degree, Pharmaceutical And Healthcare Business

High School, Science (Physics, Biology, And Chemistry)