Regulatory Assistant - Vadodara, India - Kaapro Management Solutions

Kaapro Management Solutions
Kaapro Management Solutions
Verified Company
Vadodara, India

3 weeks ago

Deepika Kaur

Posted by:

Deepika Kaur

beBee Recuiter
Description
Opening: 3 Nos


  • Job ID:

Employment Type:

Full Time- Reference:
Work Experience: 2.0 Year(s)

To 3.0 Year(s)- CTC Salary: 2.40 LPA TO 3.

00 LPA- Function: Pharma / Biotech / Healthcare / Medical / R&D- Industry: Pharma/Biotech/Clinical Research- Location:


  • Vadodara/baroda
Posted On: 25th Jul, 2023

**Job responsivities are to assist Regulatory manager

  • Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD, ACTD as well as country specific format for countries
  • Preparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbal products for country specific format in countries of African Region, Cambodia, Myanmar, CIS
  • To manage new registration / reregistration / query response / variation filling for abroad markets (AFRICAN, ASIAN & CIS REGIONS).
  • Preparation and review of COPP (Certificate of a Pharmaceutical Product).
  • Preparation and review of FSC (Free Sale Certificates)
  • Preparation, compilation and submission of variants.
  • Responsible for drafting of query response for assist countries received from MOH & Consultant.
  • Preparation of product permission for both of export products.
  • Coordination with various department of manufacturing as per the requirement of documents for dossier compilation and do follow up of finished product for sampling purpose.
  • Preparation and handling of NOC for exports countries.

Key Skills:


  • M Pharma
  • B Pharma

Company Profile:


Every decision we make and every action we take should reflect in our collective values and culture, Universal across every business unit, every role and throughout all of our location around the Globe.

They guide the way we think, act and make decisions as we learn to work to gather towards a healthier World.


We believe in making the world a healthy place to live and strive to provide quality products to every human being at affordable prices, thereby improving the quality of life for people around the Globe.

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