Senior Executive - Regulatory
Shalina Healthcare is hiring a Senior Regulatory Executive to manage product registrations and renewals for the African and Middle Eastern markets. The role involves preparing regulatory dossiers in CTD and regional formats, handling variation filings, and coordinating with local FDA and CDSCO authorities. Candidates must have expertise in regulatory frameworks and dossier management. The position requires strong coordination with internal manufacturing units and regulatory bodies.
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Experience
4+ years
Function
Operations
Work mode
Onsite, India
Company
Tier 2
What you will work on
Shalina Healthcare is hiring a Senior Regulatory Executive to manage product registrations and renewals for the African and Middle Eastern markets. The role involves preparing regulatory dossiers in CTD and regional formats, handling variation filings, and coordinating with local FDA and CDSCO authorities. Candidates must have expertise in regulatory frameworks and dossier management. The position requires strong coordination with internal manufacturing units and regulatory bodies.
TAL's take
Well-defined role in a specific pharmaceutical domain with clear regional responsibility and established experience requirements.
The JD provides a crisp, well-structured list of responsibilities and specific regulatory requirements for the defined target markets.
Must haves
- Bachelors/Masters degree in Pharmacy or Life Sciences
- Minimum 4+ years of experience in Regulatory Affairs
- Experience with African and Middle Eastern markets
- Expertise in dossier preparation and submission
- Familiarity with FDA, CDSCO, ICH, and CTD frameworks
Tools and skills
About the company
Established international healthcare company with a focus on African and Middle Eastern markets, fitting the mid-stage product company tier.
Posts mentioning Shalina Healthcare
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