About Company:
Virchow Biotech (P) Ltd is an ISO 13485:2012 and WHO-GMP certified leading global player in Biopharma sector having around 20 years of operational experience and is situated at Hyderabad, India. We also have offices located in USA. Throughout the years, the company has been successful in Research and development, clinical trials, large-scale production and Commercialization of Plasma Products, Recombinants, Biologicals and Bio-Pharmaceuticals. With 1160 employees on the board, VBPL has an expansive infrastructure, which comprises of WHO cGMP and USFDA certified state-of-art clean-room manufacturing facilities and excellent fill-finish lines for PFS, vials, cartridges and lyophilized drug products. VBPL focuses on the manufacturing of a wide range of biologicals and bio-generics by genetic engineering, classical fermentation or extraction technologies. Apart from this, we also offer Contract Research and Manufacturing services, co-development of products for various markets and customers around the world. Virchow Biotech is the part of Virchow Group incorporated in 1981. Other group companies are leading manufacturers of Sulphamethoxazole, Ranitidine, Cephalosporins and various other APIs. VBPL’s achievements include being the first company in the world to commercialize biogenerics of PDGF, Teriparatide, Pegylated Interferon and Rasburicase. VBPL has a wide product portfolio across Wound care, Gynaecology, Urology, Oncology, Vaccines and Probiotics etc. Our mission is to provide high quality Biopharma products at an affordable price. Serving economically challenged patients across the globe through Biotechnology by extending our product base across various therapeutic segments.
Website
http://virchowbiotech.com
Vacancy Details:
Job Description:
We have an immediate requirement for Asst Manager -Regulatory Affairs (Domestic-India) for VIRCHOW BIOTECH PVT LTD, Hyderabad.
Department: Regulatory Affairs (Domestic-India)
Designation: Asst Manager
No of Vacancies: 2
Qualification: M. Sc or M. Pharma
Experience: 8 to 10 years
Budget: Based on their core competency and current CTC
JOB DESCRIPTION:
1) Candidate Should have effective communication and presentation skills.
2) Responsible for Retention License application of all forms especially Injectable products through SUGAM & NSWS portal.
3) Responsible for Document Preparation related to Institutional Sales/Tenders.
4) Responsible for obtaining Legal documents from DCA, Hyderabad and CDSCO.
5) Responsible for Grant & renewal of Loan Licenses.
6) Preparation & Submission of Grant & renewal for WHO-GMP certificate (COPP’s)
7) Preparation & Submission of additional products for all forms.
8) Preparation & Submission of Grant & renewal for Test License to DCA
9) Preparation & Submission for Grant & Renewal of Manufacturing License for Injectables Products.
10) Day to day tasks -as assigned.