Job Category Medical/Healthcare/Bio-Tech
Experience 9.00 to 12.00 years
Education MPHARM, MS II
Strong knowledge and experience in handling regulatory requirements, functions with Biologicals/API/Sold Dosage particularly with filing with USFDA and EU for the final marketing approval (NDA, ANDA) •Handling of Regulated /ROW markets and with knowledge on non-clinical, clinical and BA/BE studies with Labeling requirements, electronic submission would be an added value. •Ability to evaluate weakness and provide training and develop strategies to strengthen the weaker skills in the team.
- To ensure the filing of required regulatory documents on time as per regulatory norms, take active participation from start of the project and give Regulatory strategy inputs to the team
- Liaise with Regulatory agencies, partners, customers, agents.
- Lead a team dedicated for a project and be a part of any Regulatory inspection.
- Play an important role in any decision making.
- Review of Dossiers, regulatory documents, response to deficiencies and guide team members.
- Ensuring Good Regulatory Practices are followed within the team and also proper training is provided amongst the team members.
- Perform Gap analysis
Deadline: Contact employer