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9 Coral Laboratories Jobs
Regulatory Affairs Executive
Coral Laboratories
posted 3+ weeks ago
Job Description
- Planning, compilation, review and submission of dossiers of Finished Product as per CTD, ACTD and country specific guidelines for ROW Market.
- Planning and preparing for Application for Renewal of Registrations, variations additional site, site transfer projects.
- Co-ordination with International and Domestic marketing department.
- Co-ordination with respective departments for Regulatory requirements such as documents (Quality Analysis report, Comparative study report, Validation protocols and Reports, New Product Documents, Samples and Reference standards etc.)
- Maintaining Product Registration Certificates received from respective countries and maintaining updated records of the same.
- Keeping records related to Dossiers and samples of different countries.
- Follow up with country importers regarding the submission of product in respective Health Authorities for registration/Renewal of product.
- Checking Artworks of Pharmaceutical Products and performing artwork modification as per country requirement.
- Preparation of Pack inserts as per Country specific requirement.
- Co-ordination with Account department and maintenance of records related to necessary payments.
- Responsible for regular communication with different people in respective countries.
- Conversant with current Regulatory Guidelines of dossier Submission.
- Timely answering Queries raised by Health Authorities of respective countries and customers to expedite the registration process.
- Preparation of documents required for Tenders.
Employment Type: Full Time, Permanent
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What people at Coral Laboratories are saying
Rating based on 2 Executive Regulatory Affairs
reviews
Anonymous · Other
in Mumbai
Likes
Variety of products hence a good opportunity for fresher
Dislikes
Toxic colleagues
Executive Regulatory Affairs salary at Coral Laboratories
reported by
26
employees
with 1-6
years exp.
₹2
L/yr - ₹4.7
L/yr
25%
less
than the average Executive Regulatory Affairs Salary in India
View more details
What Coral Laboratories employees are saying about work life
based on 44 employees
Strict timing
Monday to Saturday
No travel
Day Shift
Coral Laboratories Benefits
View more benefits
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