- Europe/Australia/ Canada
- Drug Dossier Authoring, Reviewing & Submission drug product dossier application (EU/UK/AU/CA)
- Product life cycle management (LCM) activities
- Assessment ofpost approval changes
- eCTD publishing
- Thorough knowledge of CMC and Module 1 requirements
- Preparation & Submission
- Authoring and review & submission of new dossier application, variation, renewal and RFI for EU (DCP/MRP/NP), UK, Australia & Canada Health Authority
- Authoring of Module 1 along with quality modules
- Assessments of post approval changes, life-cycle maintenance and ensure timely post approval regulatory activities
- Coordinate with cross-functional teams for desired regulatory data and accordingly plan & complete regulatory filing activities
- Review and finalization of artwork/label as per current QRD guideline
- Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends
- eCTD publishing
- Coordination
- Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner
- Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements
- To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D/ADL against DMF/Dossier requirements
- Reporting & Maintenance
- Maintain regulatory files/database
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AM / DM - REGULATORY AFFAIRS Jubilant Biosys Limited Accelerating Drug Discovery - United Kingdom - PharmaGroww
Description
JOB DESCRIPTION
Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients.
Jubilant Generics (JGL) is a wholly – owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively.
The manufacturing location at Mysore is spread over 69 acres and it's a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets.
Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services.
JGL's full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market.
Revenue of Jubilant Pharma is constantly increasing and during the Financial Year it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year
Kindly refer for more information about organization.
JOB DESCRIPTION :
Accountabilities Scope of work
