Executive at Biological E Ltd
Views:1403 Applications:7 Rec. Actions:Recruiter Actions:4
Biological E - Head - Regulatory Affairs (10-25 yrs)
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 1000 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
This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.