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Shalina Healthcare
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Officer - Regulatory

Officer - Regulatory

Shalina Healthcare

2 - 3 years

3 - 4 Lacs

Navi Mumbai

Posted:2 weeks ago| Platform:

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Skills Required

Regulatory

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities To prepare dossiers for product registration and renewal as per the scheduled time in African and Middle East countries in Regional as well as CTD formats as per the requirements for registration purpose. Variation filing of the products considering all the changes in Finished product. Local FDA activity as and when required. CDSCO activity as and when required. To check artworks for regulated and semi regulated countries for defined countries. To co-ordinate for documents and samples for regulatory submissions with manufacturing locations - LL & TP. Handling of queries pertaining to regulatory submissions from various regulatory authorities. Maintain and update regulatory archives and Regulatory Database of the identified countries. To arrange IMC & country embassy of legal documents. Handling specific New products projects. Any other work assigned by Regulatory Head/Technical Head from time to time. Preferred candidate profile Bachelors/Masters degree in Pharmacy, Life Sciences, or a related discipline. Minimum 2 years of experience in Regulatory Affairs, specifically within African and Middle Eastern markets. Familiarity with regulatory frameworks (FDA, CDSCO, ICH, CTD, etc.). Expertise in dossier preparation, submission, and variation filing. Strong communication and coordination skills to engage with regulatory bodies and manufacturing units. Perks and benefits Company Travel

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Shalina Healthcare

www.shalina.com/

Pharmaceutical Manufacturing

UAE Africa

1001-5000 Employees

22 Jobs

Key People

Dr. Ashok Kumar

Managing Director
Mr. David Akinyi

Chief Commercial Officer

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Officer - Regulatory

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