Multiple vacancies in AKUMS DRUGS & PHARMACEUTICALS | Require B.Pharm, M.Pharm, B.Sc, M.Sc in DRA, QA, AR&D, FR&D, IPR, stores and more
Executive/Sr.Executive-Drug Regulatory Affairs
1.Preparation of dossier in CTD, eCTD or ACTD formats for different regulated and semi-regulated market.
2.Provide the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning.
3.Ensuring effective and prompt attention and handling of queries from regulatory bodies of various countries.
4.Implement QA systems and generate SOPs.
5.Manage and facilitate all registration related activities.
6.Complete forms and requests originating from government agencies.
7.Ensuring preparation of documentation according to the requirements of regulatory body of the concerned country
8.Negotiating with regulatory authorities & obtain DCGI / local FDA approvals for marketing authorization. Update licensing and collect information on registration instructions and regulations.
Master degree in Pharmacy or equivalents. Extensive knowledge and experiences in the regulatory field. Post graduate in diploma in regulatory affairs will be preferable.
4 - 7 years of experience in Drug Regulatory Affairs. Should have experience and exposure of regulatory submission for USFDA, TGA, MHRA, TPD etc.
Excellent verbal and written communication skill.
Keep up to date with market trends and new developments utilizing information for business improvement,
Careful planning to achieve accurate and timely results.
Exp: 4-7 years
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, Production, DRA, IPR, R&D, F&D
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