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Job | Executive Regulatory Affairs - ROW Market (Pharmaceutical Formulation)-Mumbai

Mumbai, Navi Mumbai

Job description

1. Ensuring preparing & submission of Dossiers for Product registration for local and export.

2. Ensure accuracy, completeness and quality of regulatory submissions.

3. Handling local FDA, DCGI requirements.

4. Ensure that all product artwork is updated when necessary and submitted in correct format and that subsequent approved artwork is accurately recorded and communicated.

5. Ensuring accurate recording and communication of regulatory submissions, correspondence with authorities and final approval to facilitate compliance.

6. Ensuring accurate and timely responses to queries from internal and external customers.

7. Carrying out any task delegated by Export Manager which contributes to overall running of the Export Department and assisting Export Manager in marketing & business development activities.

8. Participate in training activities for career development to attain a high level of competency in all aspects of regulatory affairs.

Candidate Specifications:-

- Minimum 2 years of experience in regulatory affairs from pharmaceutical formulation background.

- Should have a strong command over written & verbal communication in English.

- Should be a permanent resident from Mumbai & have accommodation here.

- Good knowledge of ICH, WHO, and regulated market

Salary - 4.00 to 5.50 lakhs p.a

Experience 2 - 8 Years
Salary 3 Lac 25 Thousand To 5 Lac P.A.
Industry Health Care / Pharmaceuticals / Medical
Qualification B.Pharma, B.Sc, M.Pharma, M.Sc
Key Skills Good communication skill Regulatory Affairs ROW Product Manager Export Manager walk in

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