Job Description  Biological E Ltd is a leading global vaccine & pharmaceutical company which provides affordable immunization and medicines across the world. It has current turnover of around 1100 Cr and having employee strength of around 2000, growing at around 36% CAGR. Our intellectual pool of experienced scientist are based out of India and France. BE has state of the art manufacturing sites in India (Hyderabad and Dehradun).   Position title : Head Regulatory Affairs  Location : Hyderabad/ Secunderabad  Academic Background and Experience:  PG in RA/ Pharma/Life sciences background with 15 years of experience  Purpose: To drive company's initiatives for the development of vaccines and biologics from regulatory perspective  Job responsibilities  - Preparation of ANDAs/ANDSs/Dossiers for Injectable drug products for submission to USFDA, and European agencies in accordance with current regulations.  - Collate and review all master documents and other documents required for preparation of ANDA/ANDS/Dossiers  - Co-ordination with internal as well as external counterparts, collate the data/documents and prepare the dossiers/applications in e-CTD and NeeS format  - Provide necessary regulatory inputs and clearances during the development to the product development team in discussion with Team Leader  - Support commercial launch Team by evaluation of changes proposed during commercialization/ validation phase in discussion with team leader  - Regulatory knowledge sharing with PDTs and to other RA team members and contribute towards continuous learning of self & other team members  - Review registration Dossier as per the regulatory requirements.  - Filling of registration dossier in specific regulated markets.  - Reviewing of documents like product manual, BMR, stability protocols, validation protocols and validation reports of process and analytical method of regulatory compliances.  - Liaison with various departments like Chemical/API R&D, Formulation R&D, Analytical R&D, QA, QC and various manufacturing units of Biological E Ltd  - Ensuring the quality of DMFs, addressal & closure of all incomplete comments on time, and sign off on open issues to ensure the support to the DMF referenced dossiers & Registrations.  - Communicate the new/updated/revised guidelines to the CFT on a need basis & ensure that the teams are aware about the latest updates  Operating Network  Internal: QA, DQA, cross functional authorities and R&D  External: Regulatory agencies and Functional authorities  Technical Requirements: :- Understanding of various ICH / EMEA / FDA /PMDA guidelines, Technical writing skill, Good training skills, Strong analysis and data mining skills   Key personal competencies: Good Communication skills, Networking skills, Time management and work prioritization ability, Confident, Self-starter (should be able to work independently with minimal supervision

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Biological E - Head - Regulatory Affairs 

Biological E - Head - Regulatory Affairs  ,Job Description for Biological E - Head - Regulatory Affairs  in Biological E Ltd in  Hyderabad Others for (10-25) years of experience. Apply Now!

Job Description for Biological E - Head - Regulatory Affairs  in Biological E Ltd in  Hyderabad Others for (10-25) years of experience. Apply Now!