Regulatory Affairs Executive
lupin ltd
Work from Office
Full Time
Min. 3 yearsJob Description
Executive - Regulatory Affairs
Job Description
Drafting the regulatory submission files for domestic, emerging, and regulated markets.
Handling queries received from various health authorities.
Review of GMP documents as per the regulatory requirements.
Preparation of Post approval change (PAC) applications and other regulatory activities.
Coordination with the business partners for the marketing authorization applications in various geographies.
Understanding of regulatory requirements for biosimilar products is desirable.
Handling of online portals for various submissions in India, Emerging markets, and regulated markets.
Good oral and written communication are mandatory.
Work Experience
3-5 years of relevant experience
Education
Masters in Biotechnology or PharmacyPost Graduation in Biopharmaceutics or Pharmaceutical TechnologyCompetencies
Experience Level
Executive LevelJob role
Job requirements
About company
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