Regulatory Affairs Executive - International Business
Kochi, Kerala, India · Full Time
Be the first to apply
- Experience
- Any
- Salary
- INR 400,000 – INR 900,000 / year
- Openings
- 1
- Posted
- 3 days ago
- Work mode
- In office
- Education
- B.Pharma or B.Sc
- Eligibility
- Candidates with a B.Pharma or B.Sc degree in any specialization are eligible to apply.
- Resume
- Required to apply
Where you'll work
Job description
About the Role
Our client, a leading pharmaceutical company, is seeking a Regulatory Affairs Executive focused on the international business domain. This role emphasizes regulatory submissions, product registrations, coordination with third-party manufacturers, and ensuring compliance in documentation and overall business support activities.
Key Responsibilities
- Preparation and submission of regulatory documents and product registrations for international markets.
- Liaising and coordinating with third-party manufacturers to ensure regulatory standards are met.
- Ensuring regulatory compliance and maintaining proper documentation as per industry standards.
- Supporting business functions related to regulatory affairs.
Requirements
- Comprehensive understanding of CTD/eCTD dossier compilation and global registration procedures.
- Familiarity with WHO-GMP, ICH guidelines, Certificates of Pharmaceutical Product (CPP), Free Sale Certificates (FSC), and GMP certifications.
Eligibility
Applicants must hold a B.Pharma degree in any specialization or a B.Sc degree in any specialization.