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Summary

* i have completed post graduate diploma in Pharmaceutical management and masters, bachelors of Pharmacy. * a Pharmaceutical professional with 5 years experience in semi-regulated markets for regulatory submission. • considerable knowledge in the field of Regulatory Affairs, handled various market Applications in row (asean, africa, cis, latam, gulf etc.), australia •updated with latest developments with respect to submission like ctd, ich guideline and respective country specific guideline. possess a good level of computer skills.

Experiences

Current Experience

  • Senior Executive - Corporate Regulatory Affairs


    Since March 2014
    - responsible for regulatory submission for Pharmaceutical products and management of product registrations and Regulatory Compliance. - timely submission of dossiers of all categories of registration & maintaining regulatory database. - arranging additional country specific requirements, response to queries. - coordination with different departments (Research and development, Quality Assurance, quality control and Marketing department) for technical documents required for registration and query response - preparation of Strategic Planning for compilation of technical documents for regulatory submission - Responsible for regulatory submission for Pharmaceutical products and management of product registrations and regulatory compliance. - Timely submission of dossiers of all categories of registration & maintaining regulatory database. - Arranging additional country specific requirements, response to queries. - Coordination with Different Departments (Research and Development, Quality Assurance, Quality Control and Marketing Department) for Technical Documents Required for Registration and Query response - Preparation of Strategic Planning for Compilation of Technical Documents for Regulatory Submission

Past Experience

  • Regulatory Affairs Executive - International Market

    November 2011 --- February 2014
    • dossier preparation of Pharmaceutical products. • responsible for regulatory submission for Pharmaceutical products for emerging market (like kenya, botswana, cameroon, turkmenistan, hongkong, libya, kuwait, senegal, yemen, zambia, ivory coast, paraguay etc.). • development & evaluation of artwork for existing and new products • maintain Databases of the regulatory status and other pertinent details related to products and registration • responsible for maintaining all regulatory Documentation (licenses, certificates, etc) related to Manufacturing unit in Compliance with country regulations. • knowledge of various ICH guidelines, eCTD and cGMP guidelines. • co – ordination with qa, qc and production departments for getting samples and documents. • review of technical documents.

  • Technical Executive - International Market

    July 2010 --- November 2011
    work profile: • working with the international Marketing and technical team. co-ordinate with r & d Scientist to solve the technical queries of customer • co-ordinate with regulatory and qa team for international regulatory affair • job involved is of further Business Development as well as handling existing customers.

Knowledge

LinkedIn Assessment :
Regulatory affairsGMPPharmaceutical IndustryPharmaceuticsMarket researchProduct developmentRegulatory submissionsQuality AssuranceFormulationBusiness DevelopmentTechnology transferSOPeCTDRegulatory RequirementsValidationClinical trialsHPLCGeneric ProgrammingProcurementQuality SystemICH guidelinesRegulatory DocumentationQuality ControlDossier PreparationASEAN & TGA GuidelineGMP Clearance & PPF Submission - Australia

Education

  • PGD in Pharmaceutical Management in Pharmaceutical Management from B. K. School of Management, Ahmedabad in 2012
  • M.S. (Pharm) in Natural Products from NIPER, Ahmedabad in 2010
  • B. Pharm in Pharmaceutical Science from Birla Institute of Technology in 2007

Area / Region

Gujarat, India

Others

Driving License
  • No

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