Experience

Sylvester Comprehensive Cancer Center

• United States
• Hospitals and Health Care
• 300 - 400 Employee

• Regulatory Analyst

  • Dec 2022 - Present



elc International School

• Primary and Secondary Education
• 1 - 100 Employee

• Head of Department of Science (Cambridge curriculum-CIE)

  • Nov 2017 - Jul 2018

  As Head of Science, the bottomline of my efforts were ' Performance with Purpose'. Some of the notable highlights of my role are as follows: - Setting up a system based on 'Quality by Design' which would ensure a deep passion for inquiry-based learning with academic performance being a seamless consequence. - Led the Department of Science: set goals, charted actionable strategies, designed assessment frameworks for students, and appraised faculty performance. As Head of Science, the bottomline of my efforts were ' Performance with Purpose'. Some of the notable highlights of my role are as follows: - Setting up a system based on 'Quality by Design' which would ensure a deep passion for inquiry-based learning with academic performance being a seamless consequence. - Led the Department of Science: set goals, charted actionable strategies, designed assessment frameworks for students, and appraised faculty performance.



elc International School

• Primary and Secondary Education
• 1 - 100 Employee

• Lead Teacher: IGCSE Biology/Chemistry (Cambridge curriculum-CIE)

  • Aug 2015 - Jul 2017

  As a Lead Teacher, some of my key result areas were: - Transferred my passion for science and kindling young minds to think beyond the curricular content. - Created effective exploratory learning experiences for my students, a vast majority of whom secured distinction in the IGCSE exams for three consecutive years. - Mentored colleagues in their self-reflective journeys to work on the nuances of reaching exemplar teaching, assessment and learning support standards. As a Lead Teacher, some of my key result areas were: - Transferred my passion for science and kindling young minds to think beyond the curricular content. - Created effective exploratory learning experiences for my students, a vast majority of whom secured distinction in the IGCSE exams for three consecutive years. - Mentored colleagues in their self-reflective journeys to work on the nuances of reaching exemplar teaching, assessment and learning support standards.



BVM Global & BVM International Schools

• India
• Education Administration Programs
• 1 - 100 Employee

• Vice Principal

  • Jun 2010 - Jul 2015

  My bottom line for this role: 'Quality by Design' and 'Performance with Purpose'. Some of the focal areas of achievement as a passionate educator and leader are as follows: - Academic leadership for a team of over fifty faculty members including Heads of Departments, coordinators, and teachers. - Planned and executed the curricular and operational roadmap and customized mentoring for faculty members and students. My bottom line for this role: 'Quality by Design' and 'Performance with Purpose'. Some of the focal areas of achievement as a passionate educator and leader are as follows: - Academic leadership for a team of over fifty faculty members including Heads of Departments, coordinators, and teachers. - Planned and executed the curricular and operational roadmap and customized mentoring for faculty members and students.



Orchid Pharmaceuticals Ltd

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Executive

  • Jul 2007 - Apr 2010

  Formerly, Orchid Chemicals & Pharmaceuticals Ltd. Key Responsibilities: CMC Module 3 and end-to-end DMF Submissions in CTD format - Authored 'Chemistry, Manufacturing & Controls (CMC) sections in DMF. - Compiled DMF & filed high quality submissions (market-specific regulatory requirements). - Lifecycle management (approval and post-approval activities) with USFDA, EDQM and global regulatory agencies, and customers (almost 30 drug substance molecules). • U.S (USFDA): DMF, annual updates, amendments and response to queries. • E.U (EDQM): CEP dossier, renewals, revisions, response to queries, Decentralized/Mutual Recognition Procedures, ANDA support to formulators (Open part of DMF). • Japan: DMF filing as per region-specific guidelines and prepared response to queries. • Emerging markets (LATAM, China, Korea, Middle East & Russia): DMF and response to queries. - Experience with eCTD and NeeS submissions for US and EU markets. - Collaborated across departments and cross-functional teams (Quality Assurance, R & D, Manufacturing & Marketing) for timely submissions and regulatory compliance. - Worked independently and as part of a team: compiled high quality CMC submissions and managed change control of moderate complexity. - Reviewed and maintained regulatory documents (Specifications, Standard Testing Procedures, Validation reports, Certificate of Analyses, Stability Data) in the Document Management System. - Applying cGMP guidelines in regulatory processes and documentation. - Participated in internal training sessions to present regulatory updates and its implications on global submissions. Show less



Arsha Vidya Mandir

• India
• Higher Education
• 1 - 100 Employee

• Teacher of Science : Grades 5 - 8

  • Jun 2006 - Apr 2007

  An enthusiastic science teacher, I was keen to instill a love for the sciences especially Chemistry and Biology among my students. I enjoyed conducting the science exploratory sessions ( student-led workshop style learning) for middle school students. I was also responsible for creating interdisciplinary assessment papers with greater focus on analytical skill sets. An enthusiastic science teacher, I was keen to instill a love for the sciences especially Chemistry and Biology among my students. I enjoyed conducting the science exploratory sessions ( student-led workshop style learning) for middle school students. I was also responsible for creating interdisciplinary assessment papers with greater focus on analytical skill sets.