Opportunity for Executive/Sr. Executive –Regulatory Affairs @ Panacea Biotec
Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx. Rs. 830 Crores. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.We offer stimulating work environment & a career that spells growth. In tune with our plans, we require young, aggressive, dynamic, high performing and result oriented professional.
Post: Executive/Sr. Executive –Regulatory Affairs
Job Description- Regulatory & Manufacturing inputs, Documents review, Dossier filing in ROW countries, Handling of regulatory issues, Query responses, Co-ordination with distributor/Agent- To give Regulatory & Manufacturing inputs to R&D, CRD & at Mfg. site during development & Manufacturing of Exhibit batches.- Collecting, & Collating of data from functional department & filing of dossier.- Handling of issues like Changes, complaints, regulatory compliances, notifications, Post registration activities & Variation filing- Co-ordination with QA for plant inspection by NRA of respective Country.- Review of dossier & query responses. Arrangements of Samples & columns- Documents review-CMC data, Process validation, AMV, Specifications, STP, DMF, Clinical & non clinical data, Stability reports & SMF according to country specific requirements. Co-ordination & arrangement of Tender documents from PBL Locations and State Drugs Authorities.- Review of MOH approved documents- RC, NTD, Artworks, PI to inline the commercial supplies- Product Life cycle Management- PIF, IPR clearance, Dossier, Queries, Registration status, Sharing of RPI, Registration renewal, Tender documents, Collection of registration invoices.- Handling of ADR's, Submission of PSUR's, Arrangements of Licenses, RLD & upkeep of the records.
Additional Information:Experience: 4-6 yearsAge: 24-28 YearsLocation: New DelhiEducation: M.Pharm
Industry Type: Pharma/Biotech/Vaccines
Compensation: As per Industry NormFunctional Area: DRALast Date: 25th June, 2015
Apply/Forward your Resume, careers@panaceabiotec.com
Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx. Rs. 830 Crores. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.We offer stimulating work environment & a career that spells growth. In tune with our plans, we require young, aggressive, dynamic, high performing and result oriented professional.
Post: Executive/Sr. Executive –Regulatory Affairs
Job Description- Regulatory & Manufacturing inputs, Documents review, Dossier filing in ROW countries, Handling of regulatory issues, Query responses, Co-ordination with distributor/Agent- To give Regulatory & Manufacturing inputs to R&D, CRD & at Mfg. site during development & Manufacturing of Exhibit batches.- Collecting, & Collating of data from functional department & filing of dossier.- Handling of issues like Changes, complaints, regulatory compliances, notifications, Post registration activities & Variation filing- Co-ordination with QA for plant inspection by NRA of respective Country.- Review of dossier & query responses. Arrangements of Samples & columns- Documents review-CMC data, Process validation, AMV, Specifications, STP, DMF, Clinical & non clinical data, Stability reports & SMF according to country specific requirements. Co-ordination & arrangement of Tender documents from PBL Locations and State Drugs Authorities.- Review of MOH approved documents- RC, NTD, Artworks, PI to inline the commercial supplies- Product Life cycle Management- PIF, IPR clearance, Dossier, Queries, Registration status, Sharing of RPI, Registration renewal, Tender documents, Collection of registration invoices.- Handling of ADR's, Submission of PSUR's, Arrangements of Licenses, RLD & upkeep of the records.
Additional Information:Experience: 4-6 yearsAge: 24-28 YearsLocation: New DelhiEducation: M.Pharm
Industry Type: Pharma/Biotech/Vaccines
Compensation: As per Industry NormFunctional Area: DRALast Date: 25th June, 2015
Apply/Forward your Resume, careers@panaceabiotec.com
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