Microsoft Office Product Development

JAHNAVI SHETH

San Mateo, CA ***** **********@*****.***

650-***-**** www.linkedin.com/in/jahnavisheth1893 EDUCATION

Johns Hopkins University (Baltimore, MD) - Master of Science, Biotechnology (Regulatory Affairs) Aug ’15 - Dec ‘16 St. Xavier’s College (Ahmedabad, India) - Bachelor of Science, Biochemistry Jun ’11 - Apr ‘14 St. Xavier’s College (Ahmedabad, India) - Post-Graduate Diploma, Biotechnology Jun ’11 - Apr ‘14 REGULATORY AFFAIRS EXPERIENCE

Internship, Product Development Regulatory – Program Management March ’17 - Present Genentech, South San Francisco, CA

Regulatory Representative on project teams (including clinical study teams for several INDs) - provided regulatory input in support of related projects and submissions

Communicated regulatory requirements and the impact of regulations to the Regulatory Affairs Team to ensure compliance for global product development through the product lifecycle

Participated in discussions on development and implementation of global regulatory strategies. Responsibilities included facilitating weekly meetings, presentations, meeting minutes and follow-ups

Led numerous submissions. Responsibilities included direct authoring along with collaborating with cross-functional teams

Documented teleconferences and other interactions with FDA. Additional responsibilities included assisting with meeting preparation and rehearsal, meeting minutes, and follow-ups

Supported the compilation, review, and submission of regulatory documents including annual reports, new protocol, protocol amendments, safety reports, agency correspondence, etc., to health authorities by ensuring compliance with applicable submission regulations and standards

Supported label development and ensured compliance with product post-marketing approval requirements

Communicated with eCTD vendor and oversaw electronic submissions

Reviewed and interpreted scientific literature and summarized effectively in writing Independent Studies in Regulatory Science Aug ’16 - Dec ‘16 Johns Hopkins University, Baltimore, MD

Title: “Analysis of the Effect of BPCI Legal Provisions and FDA Regulatory Actions on the Introduction of Biosimilars in the Pharmaceutical Market”

Aimed to understand the challenges encountered by the FDA & the pharmaceutical industry in introducing biosimilars

Collaborated with FDA/key industrial stakeholders and conducted literature searches focused on understanding the overall impact of biosimilars in the pharmaceutical market and determining whether the BPCI Act has succeeded in promoting competition and innovation

Demonstrated that biosimilars are not expected to generate the same level of cost savings as generics SKILLS AND AREAS OF EXPERTISE

Research experience in the field of molecular and cell biology

Knowledge of FDA regulatory pathways for Food, Drugs, Medical Devices, Combination Devices, and IVDs

Understanding of regulatory requirements, including GxP and ICH

Familiarity with all phases of clinical trials and knowledge of regulatory submissions including IND, NDA, BLA, 510(k), and PMA

Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook), TouchPoint, and Adobe Acrobat

Proven ability to adapt to change in priorities and concurrently deliver to multiple deadlines by utilizing refined problem solving, analytical, and project management skills

Organized, detail-oriented, and a strategic planner with the capacity to communicate effectively with all organizational levels to accomplish tasks

Self-motivated, self-disciplined, and able to function independently as well as part of a team

Excellent written and oral communication skills, including being an active listener and engaging presenter OTHER PROFESSIONAL EXPERIENCE

Graduate Teaching Assistant Jan ’16 - Dec ‘16

Johns Hopkins Carey Business School, Baltimore, MD Course: Business Communications

Assisted students by providing guidance with demanding coursework during webinars and residency

Coordinated and monitored group projects by collaborating effectively with students and senior management

Graded homework, assignments, and exams

Lead Editor Aug ’11 - Jul ‘15

Yogi Publishers Pvt. Ltd., Ahmedabad, India

Edited and proofread the content and language of 11th and 12th grade Physics, Chemistry, and Biology textbooks RESEARCH EXPERIENCE

Independent Undergraduate Research Jun ’13 - Jul ‘14 St. Xavier’s College, Ahmedabad, India

Studied bacterial mutants and gained in-depth experience in bacterial cultures and recombinant DNA technology

Awarded Gold Medal for exceptional undergraduate research System Analyst May ’12 - Jun ‘14

X-plant® (Loyola Center for Research and Development), Ahmedabad, India

Discussed strategy implementation and product marketing with leadership team

Successfully negotiated business contracts with industry collaborators to facilitate product sale

Ensured smooth operation of the company by effectively managing stakeholder relationships

Provided scientific training and mentored 4 junior students

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