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 marketsGood knowledge of regulatory documentationFair Knowledge of Pharmaceutical Industry and its regulationsExperience in SAP MM moduleGood communication skillsExcellent negotiation skills and interpersonal skillsAbility to work in a team environment.Willingness to work on diverse projects / areas.Proficient in word / excel and PowerPoint.