B Pharma & M Pharma Regulatory Affairs Executive at Piramal Ltd

B Pharma & M Pharma Regulatory Affairs Executive at Piramal Ltd

B Pharma jobs, M Pharma job 2019. Piramal hiring Pharma candidates. Pharma jobs at Piramal Ltd. Job Opportunity for B Pharma & M Pharma candidates. Piramal Ltd Invites Bachelors in Pharma and Masters in Pharma candidates for the post of Regulatory Affairs Executive. Candidates looking for their career in the Research field may apply for this job post online. Check out all the details on the same below:

Piramal Pharma Solutions is the Contract Development and Manufacturing arm of Piramal Enterprises Ltd., with operations across North America, Europe and Asia. We are a global leader in integrated solutions and offer a unique platform of services across the drug lifecycle – from drug discovery and development to commercial manufacturing of drug substances and drug products. Our capability as an integrated service provider & experience with various technologies enable us to serve innovator and generic companies worldwide.

Job Title: Executive – Regulatory Affairs

Work Location: Zaheerabad

Eligibility: M Pharma & B Pharma

No.of posts: 01

Experience: 5 to 7 years

Salary: INR 3,50,000 – 4,50,000 P.A.

Job Description

1. Compilation and submission of DMFs in line with current guideline/ requirements in paper and electronic formats (CTD, eCTD and NeeS)
2. Responding to deficiencies raised by regulatory agencies and customer.
3. Impact evaluation of change controls and deviations against the DMF filing with global markets.
4. Notification of changes to DMF customers and getting approval for filing variations for the changes being planned and implemented to align with formulation (s) filing strategies.
5. Evaluation and filing of the post approval changes in timely manner.
6. Evaluation of DA/ POs and instruct the material quality / process needs to be dispatched to the relevant customer in line with regulatory filings & approval on concerned products.
7. Handling of NOCs, Licenses for unapproved and approved new drugs from CDSCO.
8. Support to Regulatory Authority and customer audits.
9. Submission of DMFs/ASMF/CEP with Regulatory Agencies through CESP and ESG gateway
10. Supporting to RnD during the development of new products and review of CMC documents
11. Co-ordination with internal stakeholders for timely filing of dossiers and query responses.
12. Administrative support for payment of regulatory and consultant fees, SAP and department administrative activity
13. Knowledge of regulatory guidelines and regular updation
14. Maintenance of regulatory database and compliance with regulatory SOPs.
15. Life cycle management of the DMF/ASMF/CEP
16. SPL labels and listing of customers information in SPL and update to FDA
17. Regular support and knowledge sharing to team members

Apply Online

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