Executive - Regulatory Affairs - EM Market

Executive - Regulatory Affairs - EM Market

Posted by Sun Pharma

Gurugram

Posted: imported by Jeevika

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Area Of Responsibility Area Of Responsibility 1 . New submissions: a. Review prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol), artworks etc. before initiation of Exhibit batches for adequacy. 2. Approval: Review prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations: a. Prepare and review variations as per the country requirements to support approval of changes such as API vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products etc. b. Prepare and review re-registration/PCH dossiers submit the same to regional office/ regulatory agencies 4. Regulatory compliance: a. Prepare, Review and circulate approval package to stake holders upon receipt of approval and update the same based on queries and variations. b. Ensure reposition of comprehensive product information into central repository C. Review regulatory filing impact of variations, change controls, etc. Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.Role: Regulatory Affairs Compliance,Industry Type: Pharmaceutical & Life Sciences,Department: Legal & Regulatory,Employment Type: Full Time, PermanentRole Category: Corporate AffairsEducationUG: Any GraduatePG: Any Postgraduateread moreKey Skillschemistrycompliancerosmanufacturingregulatory affairsregulatory complianceAbout the companySun Pharma 4.0 8.2K employee reviewsPharmaceutical & Life SciencesAnalytics / KPO / ResearchHighly Rated by WomenFortune India 500Forbes Global 2000Follow433.0k followers OverviewSun Pharma is the world's fourth largest specialty generic pharmaceutical company and No. 1 in India. We provide high-quality, affordable medicines trusted by customers and patients in over 100 countries. Sun Pharma's global presence is supported by more than 40 manufacturing facilities spread across 5 continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising around 3,000 scientists and R&D investments of over 6-8% of annual revenues. read moreWork With Us ProudToBeWithSun Vivek Trivedi InternationalWomen'sDay2022 Seema BhaleraoWe attribute our growth and success to our over 41,000 strong multi-cultural workforce from over 50 different nationalities. Our team has taken Sun Pharma to the heights that it has scaled and are now working to take it further up on its high growth trajectory.Company InfoLink:Sun Pharma websiteAddress:Mumbai, MaharashtraBeware of imposters! Naukri.com does not promise a job or an interview in exchange of money. Fraudsters may ask you to pay in the pretext of registration fee, Refundable Fee…Read moreSun Pharma rolesyou might be interested inSpecialist- Quality Assurance4-8 YrsKolkata, Mumbai, New Delhi, Hyderabad, Pun...Posted 30+ Days AgoChemist- In-process Quality Assurance2-6 YrsKolkata, Mumbai, New Delhi, Hyderabad, Pun...Posted 30+ Days AgoExecutive - Regulatory Affairs - EM Market5-10 YrsGurugramPosted 4 Days AgoKey highlights at Sun PharmaSalary & BenefitsHighly ratedSkill DevelopmentHighly ratedJob SecurityHighly ratedAwards & Recognitions2023We got Great Place to Work Certified2022We got Great Place to Work Certified2021We bagged the DIANA (Distribution Industry Award for Notable Achievements in Healthcare) award for ‘Best New Product Introduction/Promotion’ at the Annual Healthcare Distribution Alliance ConferenceCompany verified benefitsView allHealth InsuranceComprehensive medical coverage to ensure employee well-being.Job TrainingSkill development programs to support career growth.Salary insightsExecutive Regulatory Affairs in Sun Pharma typically earns between₹4.9 - ₹6.9 L/yrSee detailed salary breakupPowered byBenefits & PerksView all670 employees reported these benefitsLearning & Development SupportHealth & Wellness SupportTransport / Travel SupportFree MealPerformance BonusRelocation AssistancePowered by

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