Senior Executive - RA
Shalina Healthcare
Date: 1 week ago
City: Navi Mumbai, Maharashtra
Contract type: Full time
What you become a part of?
The Regulatory Affairs Executive will oversee regulatory activities related to product registration, renewal, variation filing, and compliance across African and Middle Eastern markets. This role ensures adherence to regional and international regulatory standards while collaborating with manufacturing units and regulatory authorities.
What to expect?
Qualification:
Essential: M.Sc
Experience:
The Regulatory Affairs Executive will oversee regulatory activities related to product registration, renewal, variation filing, and compliance across African and Middle Eastern markets. This role ensures adherence to regional and international regulatory standards while collaborating with manufacturing units and regulatory authorities.
What to expect?
- 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.
Qualification:
Essential: M.Sc
Experience:
- Minimum 5 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.
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