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V Ensure Pharma Technologies Pvt. ltd
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Manager / Sr. Manager Drug Regulatory Affairs

Manager / Sr. Manager Drug Regulatory Affairs

V Ensure Pharma Technologies Pvt. ltd

15 - 23 years

14 - 24 Lacs

Thane Panvel Navi Mumbai

Posted:1 day ago| Platform:

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Skills Required

Regulatory Affairs Drug Regulatory Affairs DRA Manager Regulatory Affairs RA

Work Mode

Work from Office

Job Type

Full Time

Job Description

Dear All,

We are looking candidates for our R&D Centre in Drug Regulatory Affairs for Europe market.

Company Name : V-Ensure Pharma Technologies Pvt. Ltd

Location : Koparkhairane

Role & responsibilities

1. Head and mange EU including UK regulatory team

2. Handle & lead the team for successful approval.

3. Define regulatory strategy for EU filings

4. Preparation of regulatory strategy & checklist as per country specific requirements.

5. Coordinating with cross functional departments ADL/FRD/QA/AL to procure the documents for review and compilation.

6. Coordinating with BD/Client/Vendor as per documents requirement.

7. Reviewing all CMC documents for adequacy and accuracy before compilation/ submission of Dossiers.

8. Preparing, reviewing, compiling & submission of Dossier in CTD format/regional format as per country specific requirements.

9. Review & submit all the required documents Client and or as per market requirement.

10. Client/MOH queries response for successful approval.

11. Preparation & monitoring and submission of Post approval documents

12. Review of site transfer documents for successful approval.

Preferred candidate profile

Job Role : Manager / Sr. Manager DRA

Qualification : B.Pharm / M.Pharm

Candidate must have experience in Pharma Formulation company in DRA for EU market

Perk & Benefits :

Best on Industry Standard

More Jobs at V Ensure Pharma Technologies Pvt. ltd

Manager / Sr. Manager Drug Regulatory Affairs

Thane, Panvel, Navi Mumbai

15.0 - 23.0 yrs

INR 14 - 24 Lacs

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V Ensure Pharma Technologies Pvt. ltd

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Manager / Sr. Manager Drug Regulatory Affairs

Experience & Salary

Skills Required

Work Mode

Job Type

Job Description

Dear All,

We are looking candidates for our R&D Centre in Drug Regulatory Affairs for Europe market.

Company Name : V-Ensure Pharma Technologies Pvt. Ltd

Location : Koparkhairane

Role & responsibilities

1. Head and mange EU including UK regulatory team

2. Handle & lead the team for successful approval.

3. Define regulatory strategy for EU filings

4. Preparation of regulatory strategy & checklist as per country specific requirements.

5. Coordinating with cross functional departments ADL/FRD/QA/AL to procure the documents for review and compilation.

6. Coordinating with BD/Client/Vendor as per documents requirement.

7. Reviewing all CMC documents for adequacy and accuracy before compilation/ submission of Dossiers.

8. Preparing, reviewing, compiling & submission of Dossier in CTD format/regional format as per country specific requirements.

9. Review & submit all the required documents Client and or as per market requirement.

10. Client/MOH queries response for successful approval.

11. Preparation & monitoring and submission of Post approval documents

12. Review of site transfer documents for successful approval.

Preferred candidate profile

Job Role : Manager / Sr. Manager DRA

Qualification : B.Pharm / M.Pharm

Candidate must have experience in Pharma Formulation company in DRA for EU market

Best on Industry Standard

More Jobs at V Ensure Pharma Technologies Pvt. ltd