Sr Executive-Regulatory Affairs

  Regulatory Affairs

Job title: Sr Executive-Regulatory Affairs

Company: Jubilant Pharmova

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. JOB DESCRIPTION 1. DETAILS OF THE JOB: Designation & Job : Senior Executive – India RA Level : A4 Business Unit : 269 – R&D Dosage Function : Regulatory Affairs Country : India Work Location : Corporate – Gr. Noida Reporting Manager: Associate Director – RA Manager’s Manager: VP – RA Matrix Manager: – Team Size : – Direct Reportees : – 2. PURPOSE OF THE JOB: Job Context: Challenges: 3. SCOPE & SIZE OF THE ROLE (Please indicate key metrics defining the & scope of the role) Revenue / Operating Budget — Geographical Responsibilities (Global / International / Country / Area with in Country Pharma, India Area of Impact (Dept. Location / Function or Business / Organization) JGL / Corporate / Regulatory Affairs 4. KEY ACCOUNTABILITIES: Accountabilities Scope of work India Regulatory Handling of SUGAM online portal DCGI/CDSCO/Licensing Activity Following up with the CDSCO (DCGI), CDSCO (Zonal office), State FDA and all govt. authorities for the processing of applications Preparation & Submission Preparing and submission of application for New Drug Product Manufacturing Permission and Approved Drug Product Manufacturing Permissions (CDSCO Form CT-10 and Form 29) Preparing and submission of application for Test License for New Drugs and Approved Drug in India (CDSCO Form CT-16 and Form 12) Preparing and submission of application for BE-NOC (CDSCO Form CT-05 and Form CT-16) Preparing and submission of application for Import NOC PSUR Submission in CDSCO Coordination Coordination and communication with NPPA Coordination with cross functional teams to arrange fees approval and documents required for application submissions Reporting & Maintenance Adverse events reporting PI mapping for BE studies Maintenance of trackers 5. KEY INTERFACES External Interfaces Internal Interfaces DCGI / CDSCO R&Ds and Manufacturing Sites 6. EDUCATION & EXPERIENCE minimum requirements Education Qualification (Highest) with Target Institute(s) Master / Bachelor’s degree in Pharmacy / MBA Desired Certifications: PGDRA Experience Range: 7-10 years No. of years post Highest Qualification : 7 years Desirable experience : Minimum 7 years with knowledge of India Regulatory is preferred 7. SKILLS REQUIRED: Skills Description Proficiency Level Functional Skills Regulatory Affairs Quality Assurance Behavioral Skills Business Acumen Interpersonal relationship management Communication skills (written & Verbal) 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 concepts 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: Noida, Uttar Pradesh

Job date: Sat, 04 Jun 2022 22:28:31 GMT

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