Harman Finochem Released Job Openings On 10/12/2021.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.
Harman Finochem Recruiting M.Sc,B.Pharm,M.Pharm Candidates with 8 –12 Years of Experience for Executive/ Sr. Executive– Regulatory Affair Position.Complete Details for the Executive/ Sr. Executive– Regulatory Affair as follows.
Important Details :
- Location :Shendra, Aurangabad
- Department : Regulatory Affairs
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 10/12/2021
- Mode of application :Online
- Contact : Interested candidates can share their profiles on firstname.lastname@example.org
Job Description/Skills Required
- 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.
- 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).
- Satisfactorily addressing the deficiencies conveyed by the regulatory agencies with adequate data and within stipulated timeline.
- Compilation, review and submission of DMF amendments, annual reports and revision and renewal of COS.
- Familiar with end to end process followed for development of API (R&D) till its DMF submission.
- Response to queries from the customers on the Open parts and Technical packages provided to them.
- Review of plant documents like Batch Production Record (BPR), Specifications, Change controls, etc.
- Co-ordination with Production, R&D and Quality Assurance for compilation of submission.
- Review submissions prepared by team members.
- Familiar with e-CTD submission.