Regulatory Affairs Executive job in Mumbai, Navi Mumbai by Lavina Pharmaceuticals for 2 - 5 Years Experience

Regulatory Affairs Executive

Lavina Pharmaceuticals

2 Years - 5 Years
As per industry standard
Mumbai, Navi Mumbai

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Posted: 20/12/2022

Job Description

Roles and Responsibilities
- Compilation, Preparation, review & submission of dossiers as per CTD/ACTD guidelines for product registration in ROW market, renewal & variation applications submission for registration.
- Ensure accuracy, completeness & quality of regulatory submission.
- Handling FDA requirements
- Ensure all product artworks are updated when necessary requirement & approved to submitted for registration.
- Co-ordinate and follow-up with manufacturer for documents & samples/WS required for regulatory submission.
-Responding to queries pertaining to regulatory submissions from various regulatory authorities.

Desired Candidate Profile

Atleast 3 to 4 years of experience in regulatory affairs from pharmaceutical formulation background

Should have strong command over writing & verbal communication in English

Good knowledge of ICH, WHO & semi regulated or regulated market

Work experience: 3 4 years experience in Regulatory affairs.

B. SC Graduate /M.SC / B. PHARM

Perks and Benefits

B. SC Graduate /M.SC / B. PHARM

Job Information

Job Type: Full Time
Industry: Biotechnology/Pharmaceutical/Medicine
Function : Top Management
Role: Head/VP/GM-Regulatory Affairs
Key Skills: Regulatory Affairs regulatory submissions Pharmacy Pharma formulation Healthcare Pharmaceutical Research Pharmaceutical

About Company

Lavina Pharmaceuticals
Lavina Pharmaceuticals pvt ltd. Was established in the year 2004. We are the supplier and the Exporter of Pharmaceutical Formulation like Tablets, Capsules, Injectables, Creams, Infusion, and Liquids, Pharmaceuticals Intermediates, Pharmaceutical chemicals, Inorganic capsules, We are mainly involved in supplying our several range of pharmaceutical forms in East African, West Africa and Far east Countries. Lavina Pharmaceuticals Pvt Ltd covers all product range like anti-infectives, anti- inflammatory and the arthritis, Cardiovascular, oncology, anti-diabetic, gastrointestinal and cough expectorant, multivitamin toxics.

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Regulatory Affairs Executive Lavina Pharmaceuticals