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Summary

cover letter

 

 

dear sir/madam,

 

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.

 

 

sincerely yours,

narendra babu

Experiences

Current Experience

  • Senior Regulatory Affairs Associate

    India
    Since June 2016
    1. 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.
    2. market specific and best practice guideline should follow for the each regulated market mainly for usa, canada, australia, row markets.
    3. 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.
    4. submission tracker needs to be update for each and every submissions for all test publish submission and also for live submission. 
    5. works as a Member of a team to achieve all outcomes.
    6. performs all work in support of our corporate values of collaboration, courage, perseverance, passion; demonstrates strong and visible support of our values.
    7. performs all work in accordance with all established regulatory and Compliance and safety requirements.

    all other duties as assigned

    1. 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.
    2. Market specific and Best practice guideline should follow for the each Regulated Market mainly for USA, Canada, Australia, ROW markets.
    3. 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.
    4. Submission tracker needs to be update for each and every submissions for all test publish submission and also for live submission. 
    5. Works as a member of a team to achieve all outcomes.
    6. Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion; Demonstrates strong and visible support of our values.
    7. Performs all work in accordance with all established regulatory and compliance and safety requirements.

    All other duties as assigned

Past Experience

  • Subject Matter expert India

    August 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 India

    November 2007 --- August 2011

    dmf submisssion to regulatory authority more into usa and european submission.

Personality

Self Assessment :
Attention to detailCharmCommunicativeCoordinationCreative thinkingCritical thinking

Knowledge

Self Assessment :
BiochemistryChemistryChemistry, Manufacturing, and Controls (CMC)Drug regulatory authoritiesFDAGood Manufacturing Practice (GMP)MicrobiologyPharmaceuticals

Skills and Expertise

Self Assessment :
Chemistry Manufacturing and Controls (CMC) activitiesManage projects resourcesManufacture of GMP batchesRepresent CMC team Writing regulatory documents

Education

  • Bachelor of Science in Biochemistry and Microbiology from Yuvaraja college Science in 2017

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    Account Manager - Life Sciences Field Clinical Specialist Regulatory Affairs Consultant
  • Positions I am NOT interested in:
    Regulatory Project Manager Regulatory Affairs Associate Research Assistant Regulatory and Start-Up Specialist
  • Locations I am interested in:
    Belgium Croatia Germany Netherlands Switzerland
  • Work From Home:
    Yes, 0 to 1 days per week
  • Work Regime:
    Permanent position
    BrightOwl employee
  • International:
    Yes

Area / Region

India

Others

Driving License
  • No

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