Harman Finochem Released Job Openings On 09/04/2022.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.
Vacancy Details:
Harman Finochem Recruiting M.Sc./ B.Pharm/M.Pharm Candidates with 19 –25 Years of Experience for Dy. General Manager/ AGM Regulatory Affairs Position.Complete Details for the Dy. General Manager/ AGM Regulatory Affairs as follows.
Important Details :
- Location :Aurangabad
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: ₹ 14,00,000 – 24,00,000 P.A.
- Opening date for online Application: 09/04/2022
- Mode of application :Online
- Contact :Interested candidates can share their profiles at hr@harmanfinochem.com.
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Job Description/Skills Required
1) Leading and responsible for smooth functioning of API Regulatory affairs department and timely submission of DMF/ASMF/CEP in all regions (US/EU and ROW)
2) Good exposure in CTD, Nees, and eCTD format DMF submissions with respect to the global regulatory authorities filing requirements (US, Health Canada, EMA / EU (ASMFs), EDQM (CEP), TGA, WHO & ROW, etc.
3) Strategizing regulatory support needed for business continuity & extension for API for global markets.
4) Preparation and filing of DMFs to regulatory authorities EDQM/US/EU authorities in eCTD format.
5) Experiencing in addressing the major deficiencies responses such as re-definition of starting materials, impurities controls, advanced intermediates for different products for specific authorities in the global wide.
6) Should be able to lead a team.
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