Experience - 5 to 12 Years
Qualification- B.Pharm / Mpharm / B.Sc / M.Sc
RESPONSIBILITIES
R&D and commercial sourcing
- Source vendors for API, Excipient for new formulation project for regulated markets
- Documentation for ANDA filing, open part DMF from API vendors.
- Collect all the required documentation for initial evaluation from new/alternate vendor.
- Co-ordinate with Legal team to initiate CDA to disclose the confidential data open part DMF from outsource API vendors.
Dossier extension to other market
- Co-ordinate with internal team (RA, Project management etc.) & arrange required documentation part from respective vendors for dossier extension and submission.
Technical queries
- Arrange responses for open part DMF, technical queries & deficiencies wrt API, Excipient items.
Procurement
- Arrange API, excipient for R&D to perform R&D development trial upto validation batches.
- Commercial procurement for finished dosage facilities.
QA Documentation
- Arrange VQ & other documents of API & excipients to maintain AVL at plant level, dossier filing etc.
DESIRED SKILLS
- Experience in R&D and commercial sourcing of API, excipient for new formulation projects of regulatory and ROW markets
- Good knowledge of regulatory documentation
- Fair Knowledge of Pharmaceutical Industry and its regulations
- Experience in SAP MM module
- Good communication skills
- Excellent negotiation skills and interpersonal skills
- Ability to work in a team environment.
- Willingness to work on diverse projects/areas.
- Proficient in word/excel and PowerPoint.
