Regulatory Affairs Executive

7 days ago

Savli Vadodara Gujarat, India BASE MEDICO PVT LTD Full time

**Qualification** : B.pharm/M.pharm

**Experience** : 5-7 Years

**Responsibilities**:
1] To review product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlines

2] Maintain up-to-date knowledge on international and domestic regulatory requirements.

3] Give presentations to regulatory authorities

4] Preparation and submission of dossiers of Tablets, Capsules, Ointments for ROW, EU, PIC/S and UK

5] Shall have good knowledge of formulation, Method validations, QC and QA.

6] Shall have ability to work under pressure and to tight deadlines.

7]Teamwork oriented.

8] Shall have capacity to communicate both written and verbal with regulatory bodies and give response of their queries.

9] Ensuring consistency, completeness and adherence to standards for all regulatory submissions.

10] Liaising with the FDA and HC or other regulatory authorities, to monitor the progress of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delay.

11] Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements.

12] To maintain sustainable compliance.

13] To get approval for product permission from local FDA & CDSCO.

14] To ensure compliance as per schedule-M.

16] He/She have capable to review the documents required for submission.

17] Develop regulatory strategies and implementation plans for the preparation and submission of new products.

18] Manage activities such as audits, regulatory agency inspections, or product recalls.

19] To implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.

20] Establish regulatory priorities or budgets and allocate resources and workloads.

21] To ttain staff in regulatory policies or procedures.

22] To investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.

Pay: ₹32,217.75 - ₹48,679.31 per month

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift

Supplemental Pay:

- Overtime pay
- Performance bonus

Work Location: In person

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