Regulatory Affairs Consultant - Head
KolkataFull Time
CMC
LABELING
GOOD CLINICAL PRACTICE
FDA
Job description
Minimum of 10 years of Life Science industry experience,
with substantial exposure to regulatory affairs.
Hands on experience and demonstrated expertise in Chemistry,
Manufacturing, and labeling processing
Comprehensive understanding of global regulatory framework, including
FDA, EMA, ICH and other international
standards.
Excellent communication skills both written and verbal
Meticulous attention to detail and organizational prowess
Proficiency in project management and cross-functional
collaboration
Strong analytical and problem-solving skills
Ability to navigate and interpret complex regulatory landscapes
across multiple regions
Good understanding of Quality Management Systems in the outsourcing scenarios
Good understanding of Quality Management Systems in the outsourcing scenarios
Must have skill set
CMC
labeling process
global regulatory frameworks
Good Clinical Practice
Quality Management
FDA
EMA
ICH
Skills Required
Regulatory Affairs Consultant - Head
Pharmaceuticals
Bachelor
Full Time, Permanent
Key Skills
- CMC
- LABELING
- GOOD CLINICAL PRACTICE
- FDA
Other Information
GO/JC/1061/2025
Maheshwari Balasubramanian
