SM-Program Management

  Regulatory Affairs

Job title: SM-Program Management

Company: Jubilant Pharmova Limited

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 Radiop

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 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer for more information about organization. Responsible to conduct Stage Gate I for all upcoming new product Launches of US and Canada Market Challenges: 4. KEY ACCOUNTABILITIES: Accountabilities Scope of work To conduct Stage Gate I for all upcoming New product Launches of US and Canada Market. Training To attend training organized by HR in order to enhance Management skills. MIS Reports To provide timely MIS on New Product Launches, Deficiencies and source change projects. Project Management Project Management of Regulatory deficiencies of Canada market for on time response to Health Canada Project Management of all source change projects for US and AU market. Project Management of Regulatory deficiencies of US market for on time response to USFDA. Project Management of Regulatory deficiencies of Japan market for on time response Project Management of New Product launches to commercialize new products. 5. KEY INTERFACES External Interfaces Internal Interfaces 6. EDUCATION & EXPERIENCE minimum requirements Education Qualification(Highest ) with Target Institute(s) Graduate / Post Graduate in Pharma / Science MBA – preferred Desired Certifications : Experience Range : No. of years post Highest Qualification : Desirable experience : 10-12 years of relevant experience 7. SKILLS REQUIRED: Skills Description Proficiency Level Functional Skills Understanding of Regulatory & Compliance requirements. Behavioral Skills Analytical ability. Excellent communication skills & negotiation skills General Awareness : Knows the fundamental or general understanding of concepts. Working Knowledge : Has broad job knowledge knows and applies the full range of concepts and practices. Has broad / working knowledge of the subject. Candidate should use these concept in day to day practices. Functional Expert: Candidate is certified functional expert with strong knowledge on concepts. Mastery: Candidate is subject matter expert and has command over the subject/ concepts.

Expected salary:

Location: Roorkee, Uttarakhand

Job date: Sat, 05 Feb 2022 23:28:18 GMT

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