Hardik Dwivedi

R&D Project Manager

Responsibilities:

1.Managing Research & Development Projects.

2.Regulatory Submissions in Non-Regulated Markets

1.Managing Research & Development Projects

Categories of Project handling currently :

NDA

ANDA(J)

ANDA 505(B2)

ANDA 505(B1)

Hands on experience in different dosage forms :

Tablets

Injectable

Topicals ( gel,ointments,patches,lotion,topical steroid & spray)

- Driving Projects flow with-in set time-line following ICH guidelines,Quality by Design,Critical Quality Attributes & Quality Target Product Profile for Product Development.

-Efficiency in identifying & removing bottlenecks

for smooth flow of projects.

- Maintaining daily track records for Task & Sub-tasks.

- Highlighting delays & sending reminders to Management & departments respectively.

-Managing Budget for Project & trying to keep it under target by Management.

-Presenting Project reports,status & Introducing new projects which are under pipe-line to all stakeholders & management.

- Conducting regular weekly meetings with different departments.

- Revising project priorities.

- Efficiently excicuting Process Validation Batches & Pilot Batches at Formulation Plant.

- Overlooking all Process Validation batches & data generation for regulatory filing.

Managing Regulatory Fillings - Non-Regulated Markets

-Overlooking Dossier fillings.

- Monthly allocating dossier to regulatory team.

-Setting dossier submission time-line to Ministry of Health.

- Documentation - Managing documents required for dossier compilation.

-Co-ordinating with Formulation Plant & Regulatory Team for smooth flow of data,data generation & data submission.

- Requesting Business Team for business case for new dossier initiation & filing.

Technical Skills :

- Well versed with R&D & QC studies such as :

R&D Studies Include - AMV,Dissolution Studies ,Residual Solvent Test,Assay ,Filter Validation ,Leachable & Extractable,Forced Degradation etc

QC Studies Include - Stability Study at different time-point,Accelerated stability,micro-bio etc

-Well versed with Regulatory Modules & Documents

- Drug Manufacturing File for API

- Batch Manufacturing Record,Batch Production Record, Stability study report & protocol etc

- We versed with non-regulated countries guidelines.

Cross-Functional Team - Connecting with them on regular basis.Teams mention below :

-Intellectual Property Rights,Licensing Team,R&D,

Fomulation Plant QA/QC,Regulatory Affairs,API Project Managers,Finance.