Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45+ Active Pharmaceutical Ingredients (APls) of which 10+ are Essential Drugs as per the WHO Model List. We deliver top quality products to more than 75+ countries across the globe.
Harman Finochem For Following:
- Qualification : M. Sc/ B.Pharm / M.Pharm
- Experience : 03-08+years
- Department: Regulatory Affairs
- Role: Officer/Sr. Officer/ Executive/ Sr. Executive
- Job Location: Aurangabad,Maharashtra
Interested candidates can share their profile on [email protected]
We are a leading Pharmaceutical Company into manufacturing of API’s and OSD for Regulated markets.
We are currently hiring for our
API- Regulatory Affairs located in Shendra, Aurangabad.
Designation :Officer/Sr. Officer/ Executive/ Sr. Executive– Regulatory Affairs
Education : M.Sc./ B.Pharm/M.Pharm
Experience : 3-12 Yrs.
Job location : Shendra, Aurangabad.
Job Description:
Those API experience preferred.
1) Compilation, review and submission of Type II Drug Master File (DMF) for Semi-regulated, regulated & RoW markets, Certificate of Suitability (COS) in CTD / eCTD format.
2) Compilation, review and submission of DMFs for other geographical areas like China, Canada, Australia, New Zealand, Israel, Japan, Korea, Taiwan, Brazil, Africa, Middle East, Asian Countries, Latin American countries etc (if not all, several of them).
3) Satisfactorily addressing the deficiencies conveyed by the regulatory agencies with adequate data and within stipulated timeline.
4) Compilation, review and submission of DMF amendments, annual reports and revision and renewal of COS.
5) Familiar with end to end process followed for development of API (R&D) till its DMF submission.
6) Response to queries from the customers on the Open parts and Technical packages provided to them.
7) Review of plant documents like Batch Production Record (BPR), Specifications, Change controls, etc.
8) Co-ordination with Production, R&D and Quality Assurance for compilation of submission.
9) Review submissions prepared by team members.
10) Familiar with e-CTD submission.
