. Compilation, Review and Submission of Registration Dossiers, handling
Queries and other information for countries:
. SOUTH AFRICA BRAZIL ANVISA, MEXICO, VENEZUELA
. ZAMBIA, ETHIOPIA, KENYA, SUDAN, TANZANIA, UGANDA,
BOTSWANA, NAMIBIA, MOZAMBIQUE, VIETNAM African
. VIETNAM, MYANMAR, PHILLIPPINES Asian 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
. Training in Handling of USFD Audits
THEMIS MEDICARE LTD, Mysore, Karnataka
Duration: July, – May,