Shalina Healthcare is a trusted name in the pharmaceutical and consumer healthcare industry, delivering high-quality, affordable medicines across emerging markets. Committed to regulatory excellence, we are seeking a Senior Executive – Regulatory Affairs to join our team and support global compliance and regulatory submissions.
Position: Senior Executive – Regulatory Affairs
📍 Location: Navi Mumbai, Maharashtra, India
Role Overview
As a Regulatory Affairs Executive, you will be responsible for managing regulatory activities, including product registration, renewals, variation filings, and compliance across African and Middle Eastern markets. You will work closely with manufacturing units and regulatory authorities to ensure adherence to regional and international regulations.
Key Responsibilities
- Prepare and submit dossiers for product registration and renewal in African and Middle Eastern markets, following both Regional and CTD formats.
- Manage variation filings based on updates in finished products.
- Handle local FDA and CDSCO regulatory activities as needed.
- Review artworks for regulated and semi-regulated markets.
- Coordinate with manufacturing locations (LL & TP) to collect necessary documents and samples for regulatory submissions.
- Address regulatory queries from various authorities.
- Maintain and update the Regulatory Database and archives.
- Arrange legal documents through IMC & country embassies.
- Support new product projects and other tasks assigned by the Regulatory Head/Technical Head.
Qualifications & Experience
✅ Education: M.Sc (Mandatory)
✅ Experience: Minimum 5 years in Regulatory Affairs, specifically within African and Middle Eastern markets.
✅ Key Skills:
- Strong knowledge of FDA, CDSCO, ICH, CTD regulatory frameworks.
- Expertise in dossier preparation, submission, and variation filing.
- Excellent communication and coordination skills to engage with regulatory authorities and manufacturing teams.
Join us at Shalina Healthcare and be a part of our mission to make healthcare more accessible globally!
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