Arun Kumar

Arun Kumar Email and Phone Number

Regulatory Affairs Executive - Alchemy Medicine Pvt. Ltd. @ Alchemy Medicine
Hyderabad, IN
Arun Kumar's Location
Hyderabad, Telangana, India, India
About Arun Kumar

Arun Kumar is a Regulatory Affairs Executive - Alchemy Medicine Pvt. Ltd. at Alchemy Medicine.

Arun Kumar's Current Company Details
Alchemy Medicine

Alchemy Medicine

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Regulatory Affairs Executive - Alchemy Medicine Pvt. Ltd.
Hyderabad, IN
Website:
alcmed.com
Employees:
37
Arun Kumar Work Experience Details
  • Alchemy Medicine
    Regulatory Affairs Executive - Alchemy Medicine Pvt. Ltd.
    Alchemy Medicine
    Hyderabad, In
  • Alchemy Medicine Pvt. Ltd.
    Regulatory Affairs Executive - Alchemy Medicine Pvt. Ltd.
    Alchemy Medicine Pvt. Ltd. Jul 2021 - Present
    Hyderabad, Telangana, India
    Role in Dossier Preparations: ➢ Responsible for compilation and submission of Dossier (Both CTD & Country Specific) for:African Countries: DR Congo, Kenya, Ghana, Gambia, Togo , Zambia, Guinea, Benin, Nigeria.Asian Countries: Myanmar, Cambodia, Georgia, Afghanistan, Yemen, Tajikistan, Azerbaijan, Uzbekistan, Kazakhstan.South American Countries: Ecuador, Bolivia, Guyana.➢ Responding to queries related to dossiers and other renewal certificates from regulatory agencies.Role in Artworks Development:➢ Coordinating with Q.C department and designer and for artworks development and review of Cartons, Foils, Literature and Labels and Visual aids etc. and approving them.
  • Lactonova Nutripharm
    Regulatory Affairs Executive
    Lactonova Nutripharm May 2020 - Jun 2022
    Hyderabad, Telangana, India
    ➢ Responsible for compilation and submission of Dossier (Both CTD & Country Specific) for:Asian countries: Myanmar, Cambodia, Malaysia, Philippines, Singapore, Nepal, Afghanistan.African Countries: Ghana, Nigeria and ZambiaMiddle East countries: Iran and Dubai (UAE)CIS Countries: Srilanka, Azerbaijan, Ukraine, Uzbekistan.➢ Responding to queries related to dossiers and other renewal certificates from regulatory agencies.➢ Documents preparing and applying the new and existing certificate. i.e.: FSSAI, FSC, ISO, HACCP, Pharmexcil, WHO-GMP, Trade Marks and GMP-Ayush Licenses, MSME.➢ Reviewing technical documents like Formulation certificate (FC), Master formula record (MFR), Batch manufacturing record (BMR), Stability data, Certificate of analysis (COA), Finishedproduct specification (FP-Spec), Finished product standard testing procedure (FP-STP), process validation.➢ Cross checking RDA value limits in various compositions as per domestic and exports requirements.➢ Tender documents preparing for domestic and export.➢ Supporting business development teams in composition development.➢ Issue the internal dispatch advises for production purpose.➢ Coordinating with the internal departments for various documents for dossier preparations and other certificate renewals.➢ Coordinating with designer for artwork development and review of Cartons, Foils, Literature and Labels and Visual aids etc. and approving them.➢ Preparing Certificate of origin (COO) for export purpose.➢ Sample arrangement for domestic and export and tracking them till it reaching destination.
  • Sparsha Pharma International Private Limited
    Regulatory Affairs Junior Executive
    Sparsha Pharma International Private Limited Aug 2018 - Apr 2020
    Hyderabad, Telangana, India
    1) Preparing Dossiers and submissions to regulatory authorities for products registration.2) Queries responding related to dossier and renewal certificates.3) Reviewing technical documents like process validation, AMV, Stability data, COA, FP-Specification, FP-STP, MFR, BMR etc.4) Preparing and applying the new and renewal certificates and Maintaining records as assigned. i.e.: GMP, WHO-GMP, GLP, FSC, Repacking license, Market standing certificate,5) Coordinating with internal departments.
  • Mylan Laboratories Limited
    Regulatory Affairs Apprentiship
    Mylan Laboratories Limited Jun 2017 - Jun 2018
    Hyderabad, Telangana, India
    ➢Responsible for dossier compilation and supporting the manager for products registration. (Both CTD & Country Specific) for RAW Market.➢ Compiled and helped in dossier submissions.

Arun Kumar Education Details

Frequently Asked Questions about Arun Kumar

What company does Arun Kumar work for?

Arun Kumar works for Alchemy Medicine

What is Arun Kumar's role at the current company?

Arun Kumar's current role is Regulatory Affairs Executive - Alchemy Medicine Pvt. Ltd..

What schools did Arun Kumar attend?

Arun Kumar attended Cvm College Of Pharmacy, Jyothishmathi College Of Pharmacy.

Who are Arun Kumar's colleagues?

Arun Kumar's colleagues are Mohd Waseem, Sugamini Chadalavada, Rupesh Kumar, Irshad Saif, Manisha Chauhan, Sunil Kumar, Kavitha Kummari.

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