Pharma Regulatory Affairs Executive at JB Pharma – Apply on Rasayanika
Regulatory Affairs Executive – JBPharma
Job Description
Budget: 4-5 LPA
Experience: 2-4 years
Interview Mode: F2F/ Virtual
Location: Mumbai
About the Role:
Responsible for the preparation and compilation/review of registration dossiers as per the current regulatory requirements of the Russia CIS / ROW region to obtain the necessary authorization.
Responsibilities:
- Maintain awareness and knowledge of current regulatory guidelines/legislation and ensure best regulatory practice at all times.
- Provides regulatory guidance to internal stakeholders, to allow them to make key decisions on business-critical activities and project feasibility.
- Review, analyse, and prepare/compile documents generated by R&D, Operations, QA, and other related departments as per current regulatory requirements.
- Handling queries from Regulatory Bodies from time to time.
- Regulatory gap analysis and variation application filing accordingly.
- Handling Lifecycle management projects. Coordinating project meetings and decision-making processes.
- Review of New product development documents.
- Maintaining regulatory trackers.
- Providing Master dockets to the site.
- Review of Change control documents.
- Additional responsibilities may be given in addition to the above as per business requirement and JD can be altered at the discretion of the superiors.
Qualifications: M.Pharma
Required Skills: Should have a minimum of 2-4 years of experience.
Preferred Skills:
Excel, Database, etc.Keywords: Pharma Regulatory Affairs Executive at JB Pharma – Apply on Rasayanika. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
