Regulatory Affairs Manager
Edkem Pharmaceuticals Ltd. is seeking a Regulatory Affairs Manager to join their team in Ahmedabad. The role focuses on overseeing regulatory compliance, managing submissions, and maintaining quality systems for their pharmaceutical manufacturing operations. Candidates are expected to be proficient in CTD and ACTD dossier requirements and hold a degree in Pharmacy or Life Sciences. This is a full-time, on-site position.
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Experience
Experience not specified
Function
Operations
Work mode
Onsite, India
Company
Tier 2
What you will work on
Edkem Pharmaceuticals Ltd. is seeking a Regulatory Affairs Manager to join their team in Ahmedabad. The role focuses on overseeing regulatory compliance, managing submissions, and maintaining quality systems for their pharmaceutical manufacturing operations. Candidates are expected to be proficient in CTD and ACTD dossier requirements and hold a degree in Pharmacy or Life Sciences. This is a full-time, on-site position.
TAL's take
Stable domain-specific role at an established manufacturer, though lacks explicit compensation or YOE details.
Clear role expectations, specific regulatory requirements, and well-defined scope for a pharma manager.
Must haves
- Strong knowledge of Regulatory Compliance
- Experience in Regulatory Affairs and Regulatory Submissions
- Understanding of Quality Systems in a pharmaceutical setting
- Familiarity with CTD and ACTD dossiers
- Bachelor's or Master's degree in Pharmacy or Life Sciences
Tools and skills
About the company
Established pharmaceutical manufacturer, tier 2 as it is a regional player without global flagship status.