Position : Regulatory Affairs Executive
Region : With Europe regulatory filing experience
Department : Regulatory Affairs
Yrs of exp : 6yrs+
Location : Central line, Thane District, Mumbai, MH, India
Responsibility :
- Be responsible for managing regulatory submissions in terms of collection of data, review of site variations
- Be up-to-date with Guidance and MHRA & EU Regulations and provide assistance in evaluating proposed changes and deciding strategy, BE study queries
- Post approval change management
- To assist in thorough interpreting of RFIs, and outlining plan of action to respond to deficiencies
- To provide support/assistance to UK RA team by coordinating with suppliers/CMOs on Regulatory matters
