Experience spanning three decades in healthcare, with a wide range of formulations to meet the needs of ailing humanity, Intas Pharmaceuticals headquartered at Ahmedabad (India), is now a force to reckon with, in the global pharma horizon. With expertise in a range of formulations, from tablets to injectables to newer drug delivery systems, Intas is currently ranked 17th among the Indian Pharma majors. A variety of initiatives in Research and Development, patents and ANDA filing, NDDS, quality manufacturing support, along with approvals by regulatory authorities of many countries has made Intas a global healthcare provider. Pioneering efforts in providing medications for both chronic and acute medical conditions, has truly led Intas live up to its corporate line Expressions for a Healthy Life.
Job Description
Desired Candidate Profile
FUNCTION: IRA – EU Variations.
Candidate required 1 – 5 Years of expertise, should be well versed to identify, Compile & submit the EU variation (Specifically Quality & Safety variations) through agency portal.
Should be involved in CRF evaluation, Regulatory text preparation for agency submission along Coordination with countries for national approval and national text preparation.
FUNCTION: ACCORD – RA (EU Artwork & Labelling).
Candidate should have 1 – 5 Years of expertise, should be known to Artwork Preparation & Changes, Should be involved in CRF evaluation, development of Product information (SPC/PIL/Label), submission of Bromi/article 61 (3) to MHRA for mockup changes, review various site transfer/in-license artwork, Co-ordination with studio and third parties for artwork preparation.
FUNCTION: QA – FDA & DCGI (Regulatory Work).
Candidate having 1 – 5 Years of expertise, should be known to Formulation & Biotech Molecule Registration with FDCA / DCGI, Involve in BE NOC for Export, Import application, Registration of various forms (Form -29, form 41, form CT 16, form CT 11 etc.), M&M & CT /BE application/Written confirmation certificate/GMP Inclusion/FDCA Application/COPP & FSC Applications, Filling dossers for the neighbour country like NEPAL.
Time and Venue
1st October, 10.00 AM – 3.00 PM
Venue: Intas Corporate Office, 255, Sarkhej – Gandhinagar Hwy, Near Sola Bridge, Near MAGNET CORPORATE PARK, Thaltej, Ahmedabad, Gujarat 380054
Email: sdwivedi@intaspharma.com
