1 Opening(s)
1.0 Year(s) To 2.0 Year(s)
2.20 LPA TO 2.80 LPA
Job Location : Mahape, Nearest Station Ghansoli (Navi Mumbai)
Look for people from Navi Mumbai or Mumbai Only
Only Female Candidates required
Qualification : B.Pharm / M.pharm
Experience : 1yr – 3yr
Salary : 1.42lpa – 2 .80lpa
Profile :
Experience in preparing Dossiers in CTD, ACTD, Country Specific Dossiers.
Countries : ROW and Latum
Job Description:
Dossier Preparation along ...
1 Opening(s)
10.0 Year(s) To 15.0 Year(s)
10.00 LPA TO 15.00 LPA
Job Description
-Compilation and submission of eCTD dossier for new product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US)
-Hand on experience in preparation of CTD section as per regulatory requirements of different region
-Having experience in preparation of query response and PAS, CBE and annual report.
-Have ability to co-ordinate with ...
1 Opening(s)
2.0 Year(s) To 3.0 Year(s)
1.00 LPA TO 3.00 LPA
Job responsibilities 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 ...
1 Opening(s)
2.0 Year(s) To 3.0 Year(s)
2.00 LPA TO 3.00 LPA
Job responsibilities :
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 / preregistration ...
1 Opening(s)
6.0 Year(s) To 7.0 Year(s)
6.00 LPA TO 7.00 LPA
Job Description: Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations.
? Preparation, Compilation & Review of Registration documents that include Administrative & Technical.
? Reviewing the technical documents provided by QA, QC, Production providing them the report of shortcomings & ...
1 Opening(s)
2.0 Year(s) To 10.0 Year(s)
2.00 LPA TO 5.00 LPA
Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority.
Well versed with the guidelines of ICH and other regulatory.
Preparation of documents for license application.
Preparation of documents for COPP, FSC and other legal documents including product permission
Preparation of registration documents as per ACTD , CTD ...
1 Opening(s)
3.0 Year(s) To 5.0 Year(s)
3.50 LPA TO 4.50 LPA
Position: RA Executive
Location: Vapi
Experience: 3- 5 Years
Industries: Pharma
Responsibilities:
To Dossier Compilation as per country guideline (ACTD/CTD & Country Specific format).
Review of all documents related to dossier preparation such Quality and administrative documents.
Coordination with various departments such as Quality assurance, Production, Quality control etc. For collection of various ...
3 Opening(s)
2.0 Year(s) To 3.0 Year(s)
2.40 LPA TO 3.00 LPA
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, ...
1 Opening(s)
4.0 Year(s) To 5.0 Year(s)
3.00 LPA TO 4.00 LPA
Duties and Responsibilities :
Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
Timely compile materials for license renewals, updates and registrations
Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted ...
1 Opening(s)
2.0 Year(s) To 3.0 Year(s)
2.40 LPA TO 3.00 LPA
Job responsibilities:Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD,ACTD as well as country specific format for countriesPreparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbalproducts for country specific format in countries of African Region, Cambodia, Myanmar, CISTo manage new registration / preregistration / ...