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<pre>Array ( [var] => cut_url ) </pre> Resume for shakeel S. for Researcher / Scientist / Biotechnology & Pharmaceuticals in Bangalore, India. Search More Resumes for Researcher / Scientist on #7G8C87JL7

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Resume for shakeel S. for Researcher / Scientist / Biotechnology & Pharmaceuticals in Bangalore, India

Occupation: Researcher / Scientist Industry: Biotechnology & Pharmaceuticals
Country: India City: Bangalore
State: Karnataka ZIP: 560010

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Mohammed Shakeel.S Near Haram Center
Mob: + Riyadh
Saudi Arabia
To obtain a challenging career in the field of Regulatory Affairs and to work in an environment
where my skills are utilized to the best.
Having total years of experience in the field of pharmacy. It includes one year in pharma
marketing and Five years’ experience in the field of Regulatory Affairs.
My Expertise.
> Expertise to prepare, Compile and file the MAA in EEA through DCP and National
> Compilation of NtA to CTD dossiers.
> Prepare and file Dossier to WHO prequalification Programme.
> eCTD Submissions
> Prepare and Filing the post approval changes PAS, Variations to EU &WHO
> Complete Regulatory compliance for marketed products.
> Prepare and file Dossier for Rest of the world markets and semi regulated markets.
> Support to Preparation and submission for Indian Regulatory authorities for success full
approvals Import, BA/BE, Export etc..
> Knowledge on various guidelines EU,US,WHO & ICH
> Evaluate Dossiers
> Query handling and review of documents for successful approvals
> Review of Prototype documents for New submissions etc.Development projects
> Change control assessments for quality regulatory impacts.
Organization: Riyadh Pharma Medical and Cosmetics Products Company.
Riyadh Kingdom of Saudi Arabia
Designation: Senior Supervisor Registrations
Duration: Months December to Till date
Job responsibilities:
• Setting up New Registration department.
• Complete support for MNC’s of EU for their submissions in middle east.
• Setting up strategies for successful regulatory submissions
• Preparation of Departmental SOP’s
• Regulatory Compliance and audit.
• Compilation of CTD dossiers to Saudi Food and Drug administration Module
• Assessment and compilation of Variation application package for Saudi Food and Drug
• Compilation of CTD dossier to GCC countries Kuwait.UAE,
• Complete Deficiency response Handling to Saudi Food and Drug administration
• Complete Deficiency response Handling to GCC countries Kuwait.UAE,
• Training Subordinates for successful compilation of dossiers for SFDA and GCC countries
• Discussion with R&D, QA & QC for Successful submission of dossier and timely
availability of documents for submissions.
• Review of Documents for Successful submissions of CTD dossiers.
• Check list preparation for Submissions of CTD dossiers.
• Review of Raw material specifications and Finished Product Specifications to comply
with Current USP/BP/Ph.Eur Monographs.
Organization: Sandoz Pvt Ltd Thane,Maharastra, INDIA.Ê
Designation: Scientist II Regulatory affairs
Duration: Two years. and Months May to Sep
Job responsibilities:
Compilation of Registration Dossiers to:
• Prepare, Compile and file the MAA in EEA through DCP and National procedure.
Using IBM score application.
• Compilation of Variation dossier to EU market. CTD, eCTD and NeeS submissions.
• Review of prototype documents for development projects.
• Prepare ,Compile and file Prequalification dossiers to WHO
• Compilation of variation dossiers to WHO,
• US market PAS
• Carry out Regulatory compliance for the marketed products.
• Compilation of dossiers and Complete documentation support for WHO GDF and other
related tenders .
• Review of Third party dossier and Documents follow up with third parties for successful
• Coordination with various departments’ viz. Formulation development, Quality
Assurance, Analytical development for timely availability of data.
• Deficiency response to meet deadlines.
> Other than the above I am also associated for the following responsibilities
Preparation of presentation on the status of regulatory affairs dept.
Assisting the lead in resource allocation, estimation, and management of project.
Providing comprehensive information to the marketing team for higher productivity.
Preparation of Departmental SOP’s
The trainings that I received in my tenure can be summarized as:
• Training on eCTD submission using IBM score application
• Training on SUPAC requirements for US market
• Training on regulatory requirements for Canada, Singapore, and Japan market.
• Training on GDP and CAPA
• Training on Microbiological Examination
• Training on New EU Variation guidelines.
Organization: Strides Arcolab Ltd. Bangalore, INDIA.Ê
Designation: Executive
Duration: One year and months. Sep to May
Job responsibilities:
Preparation of Applications for Drug Controller, Karnataka which includes the following:
. Additional Product Applications
. Applications for Free Sale Certificate
. Applications for Certificate of Pharmaceutical Product CPP
. Applications for Test License
. Applications for other Tender Documents
. Applications for fresh License and Loan License
. Applications for GMP
. Applications for DCGI for import registration, Import of drugs and BE
studies etc.
. Compilation, Review and Submission of Registration Dossiers, handling
Queries and other information for countries:
. Preparation of Check lists for Ethiopia, Kenya, Sudan, Tanzania, Uganda,
Zambia, Botswana, Namibia, Mozambique, Vietnam, Myanmar and
. Ability to understand the registration formats of various countries.
. Ensure the preparation of Registration Dossiers to the entire satisfaction of
the Regulatory Authorities of the importing countries.
. Coordinate with Plant, QC, Production and R&D Departments.
. Coordination with Legal department for GMP/FSC/COPP and other
documents for Registration Dossiers
. Maintenance of Art Works, Labels
The Value Addition that I have provided in my tenure can be summarized as:
. Prepared country specific Dossiers format by referring guidelines,
Customer Queries and deficiencies received earlier.
. Prepared Check List to assess the completeness of the Dossiers
. Preparation of Standard Operating Procedure SOP documents
. Documentation support for marketing Team for various tenders .
The trainings that I received in my tenure can be summarized as:
. Underwent extensive training in Regulatory Affairs Department
. Participated in training programmes related to cGMP, Sterilization Techniques,
IPR, Analytical Method Development and Validations, Personality Development
and Management
. Training in Handling of USFD Audits
THEMIS MEDICARE LTD, Mysore, Karnataka
Duration: July, – May,
Medical Representative
Job responsibilities:
The experience during this tenure can be summarized as:
. As a Medical Representative, I gained extensive knowledge of the various
medicines in the market
. Gained good communication and presentation skills while interacting with various
. Increased the Sales Target by % which was a good achievement during the
Degree: B.Pharmacy
College: Manipal College of Pharmaceutical Sciences, Manipal, Karnataka
Result: .%
Diploma: Diploma in Pharmacy
College: National College of Pharmacy, Shimoga, Karnataka
Result: .%
PG Diploma: Regulatory Affairs

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