Job Title: Manager - Regulatory Affairs
Purpose of Job
Purpose of the Job is to handle regulatory activities for domestic region.
Skill Required
10+ yrs of experience of handling domestic region submissions and other relevant activities. Conducting IBSC and RCGM SEC meetings.
Experience of drafting, review and finalization of DCGI query responses.
Co-ordination and negotiations with CFTs
Strategy and planning for technical documents and technical inputs for MAA applications
Roles and Responsibilites
10+ yrs of experience of handling domestic region submissions and other relevant activities. Conducting IBSC and RCGM SEC meetings.
Experience of drafting, review and finalization of DCGI query responses.
Co-ordination and negotiations with CFTs
Strategy and planning for technical documents and technical inputs for MAA applications
Qualification Required
B Pharm or M.Pharm from a reputed university
Competencies
Relevant skills / Industry experience
Relevant professional / Educational background
Any other requirements (If any)
Compensation / Reward
Biotech, Ahmedabad, GJ, IN, 382213