MUMBAI · FULLTIME
Manager - Regulatory Affairs (Europe) - Formulation

Mac Chem Products
Mumbai · onsite · Posted 4d ago
Sourced from
Undisclosed9–14 yrsfulltimeMumbai
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Section · 01
About this role
Registrations in EU & GCC markets. Experience in eCTD dossier preparation and submission. Serialization, data integrity, and quality risk management. Cross-functional global teams and external partners. Complex injectables, sterile products.
Regulatory approved companies from EU, ANVISA, WHO, FDA etc
Required Candidate profile
Preferably in injectable with a knowledge of GMPRegulatory approved companies from EU, ANVISA, WHO, FDA etc
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Section · 02
Skills
EuropeanDossierEuropeCompilationRegulatory AffairsDossier PreparationRAInjectablesFormulation
Section · Company
About Mac Chem Products

Mac Chem Products
Pharma
175
employees
Andheri
India
₹3.8L PA avg
Avg at Mac Chem Products
About
Mac-Chem, a proud member of the NMM group, is a leading pharmaceutical company specializing in Oncology, General APIs, and Bulk Sterile. Founded in 2010 to ensure reliable API availability. We are GREAT PLACE TO WORK Certified
Industries
Pharma
Employee ratings
10 reviews
3.0/ 5
Culture
2.4
Career growth
2.5
Work-life
2.5
Employees rate it well for
Compensation & Benefits30Skill Development30
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