i have enclosed my resume, for your kind perusal and consideration which elaborates my academic and professional achievements and candidature for the job.
i am bsc graduate from University of mysore working as a “senior Associate - Regulatory Affairs” in “apotex Research”, bangalore (india) during my tenure with apotex Research, i acquire my experience in the functions of Regulatory Affairs. previously i have worked in accenture. totally i have 9 years and 10 months experience in Regulatory Affairs and Operations department.
i have imbibed the work Ethics, values and systems of the organization. therefore, my contribution to the organization, where i have worked has been meaningful, substantial and professionally contributing.
now, i wished to take up assignments with wider scope and challenging aspects that contributes for the organizations and potential for self-fulfillment.
Senior Regulatory Affairs AssociateIndia
Since June 2016
- eCTD submission review and Validation for usa, canada a as per the workload plan and also prioritize the low level submission for australia and row market as per the requirements.
- market specific and best practice guideline should follow for the each regulated market mainly for usa, canada, australia, row markets.
- to check thoroughly market specific guideline to review the eCTD submission to ensure all the issues been resolved along with best practice issues and Validation issues as well.
- submission tracker needs to be update for each and every submissions for all test publish submission and also for live submission.
- works as a Member of a team to achieve all outcomes.
- performs all work in support of our corporate values of collaboration, courage, perseverance, passion; demonstrates strong and visible support of our values.
- performs all work in accordance with all established regulatory and Compliance and safety requirements.
all other duties as assigned
- eCTD submission Review and validation for USA, Canada a as per the workload plan and also prioritize the low level submission for Australia and ROW market as per the requirements.
- Market specific and Best practice guideline should follow for the each Regulated Market mainly for USA, Canada, Australia, ROW markets.
- To check thoroughly market specific guideline to review the eCTD submission to ensure all the issues been resolved along with best practice issues and validation issues as well.
- Submission tracker needs to be update for each and every submissions for all test publish submission and also for live submission.
- Works as a member of a team to achieve all outcomes.
- Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion; Demonstrates strong and visible support of our values.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
All other duties as assigned
Subject Matter expert IndiaAugust 2011 --- June 2016
eCTD submission mainly for usa and team handling around 5 members, project delivery on time. based on day to day activity.
Regulatory assistant IndiaNovember 2007 --- August 2011
dmf submisssion to regulatory authority more into usa and european submission.
Attention to detailCharmCommunicativeCoordinationCreative thinkingCritical thinking
BiochemistryChemistryChemistry, Manufacturing, and Controls (CMC)Drug regulatory authoritiesFDAGood Manufacturing Practice (GMP)MicrobiologyPharmaceuticals
Skills and Expertise
Chemistry Manufacturing and Controls (CMC) activitiesManage projects resourcesManufacture of GMP batchesRepresent CMC team Writing regulatory documents
Bachelor of Science in Biochemistry and Microbiology from Yuvaraja college Science in 2017