Harman Finochem Ltd. is a reputed Pharmaceutical Company engaged in Development, Manufacturing and Export of Quality APIs and OSD Products. The Company has state-of-the-art EU audited OSD Manufacturing facilities and R&D Centre at Shendra, Aurangabad and looking for candidates with working background in USFDA, EU approved facilities conversant with cGMP norms.
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 : Executive/ Sr. Executive– Regulatory Affair
- Education : M.Sc./ B.Pharm/M.Pharm
- Experience : 8-12 Yrs.
- Job location : Shendra, Aurangabad.
- Those API experience preferreed.
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.
Interested candidates can share their profiles on email@example.com.