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Formulation Regulatory Affairs Executive/ Assistant Manager

Formulation Regulatory Affairs Executive/ Assistant Manager

3 - 8 years

|

3 - 7 Lacs

Hyderabad

Posted:2 months ago| Platform:

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Skills Required

Dossier Preparation Regulatory Affairs Row Market Anda CMC Solid Orals OSD Compilation Submission Approvals Actd Ectd RA ICH CTD Formulation Dossier Row

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Administrative documents requirements (COPP, Mfg. License and Import License) . Registration information management system updates on regular basis.

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Hetero

www.heteroworld.com

Pharmaceuticals

Hyderabad

10,000+ Employees

84 Jobs

Key People

Dr. B.P. Singh

Founder & Managing Director
Srinivas K. Reddy

CEO
Pradeep K. Varma

Chief Financial Officer
Vikram Kumar G.

Chief Operating Officer

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