Assistant Manager / Sr. Executive

Assistant Manager / Sr. Executive

Posted by Firm in Pharma & Life Sciences Domain

Ahmedabad

Posted: imported by Jeevika

JobsPopular categoriesIT jobsSales jobsMarketing jobsData Science jobsHR jobsEngineering jobsJobs in demandFresher jobsMNC jobsRemote jobsWork from home jobsWalk-in jobsPart-time jobsJobs by locationJobs in DelhiJobs in MumbaiJobs in BangaloreJobs in HyderabadJobs in ChennaiJobs in PuneCompaniesExplore categoriesUnicornMNCStartupProduct basedInternetExplore collectionsTop companiesIT companiesFintech companiesSponsored companiesFeatured companiesResearch companies by AmbitionboxInterview questionsCompany salariesCompany reviewsSalary CalculatorServicesAI career toolsNeo AI job agentResume score checkerAI resume makerInterview Q&AAI mock interviewLive AI interviewPremium servicesNaukri ProMost popularExpert resume writingExpert power profileAI BootcampsNewFree resourcesResume samplesJob letter samplesSearch jobs hereLoginRegisterFor employersBuy onlineNaukri Talent CloudEmployer LoginAssistant Manager / Sr. ExecutiveNivagen Pharma (india)3.713 Reviews5 - 10 yearsNot DisclosedAhmedabad( Satellite )Posted: 2 weeks agoOpenings: 1Applicants: 100+Assistant Manager / Sr. ExecutiveNivagen Pharma (india)3.713 ReviewsJob description Job description for Asst. Manager/Sr. Executive - Regulatory Affairs Department (USA market)Location: Nivagen Pharma (INDIA) Pvt. Ltd., Satellite, Ahmedabad, INDIAReport to: Manager, Regulatory Affairs, Nivagen PharmaceuticalsJob Description:1. Develops and implements submission strategies for PIND, 505(b)(2); NDAs; ANDA.2. Leads and ensures implementation of the planning, writing and review of all regulatory submissions to support PIND/IND/NDA/505(b)2; ANDA submissions including FDA meeting requests and packages.3. Critically reviews and approves documentation from clinical development, non-clinical development, iPSP, Research and Development (R&D), Quality, Technical Operations, Labeling and other appropriate departments, internal and stakeholders, vendors and consultants.4. Ensures that project timelines are developed and communicated; evaluates changes to maintain submission goals and timelines; communicates any delays along with the rationale.5. Interprets regulations and guidance documents and provides strong regulatory leadership to project teams to ensure regulatory success.Candidate Profile: 1. Minimum of M.Pharm./M.Sc./Ph.D. with 5 to 10 years experience in the pharmaceutical industry, with at least USFDA working experience.2. Strong analytical skills and business acumen specific to operational activities and product launches in generics.3. Cross-functional collaboration skills with the ability to network with different functional areas and integrate cross-functional deliverables.4. Sterile injectable and Solid Oral Dosage form registration experience candidates are required.5. Proficiency in eCTD software, SPL, MS Office, MS Project.6. Strong oral interpersonal and written communications skills.Role: Legal & Regulatory - Other,Industry Type: Pharmaceutical & Life Sciences,Department: Legal & Regulatory,Employment Type: Full Time, PermanentRole Category: Legal & Regulatory - OtherEducationPG: M.Pharma in Pharmacy, MS/M.Sc(Science) in ChemistryDoctorate: Ph.D/Doctorate in PharmacyKey SkillsSkills highlighted with ‘‘ are preferred keyskillsUSFDAANDARegulatory AffairsCMCNDAeCTDParenteralDossierInjectablesUS MarketAbout companyAbout the Company:Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.Company InfoAddress:535 AND 536,ISCON EMPORIO,NEAR STAR BAZAR, , AHMEDABAD, Gujarat, IndiaBeware 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 moreSimilar jobsAsst Manager /Dy Manager/ Manager For API Regulatory Affairs Dept (RA)MSN Group3.63438 reviewsHyderabad(Pashamailaram)Regulatory AffairsAPIBulk DrugsDmfRADrug Regulatory AffairsDrugBulkPosted 13 Days AgoRegulatory Affairs - Asst. Manager, Senior Executive,Maan Pharmaceuticals3.612 reviewsMumbai(Worli)Regulatory AffairsDossier PreparationProduct RegistrationProduct Life Cycle ManagementDocumentationDossierRegulatoryLife Cycle ManagementPosted 16 Days AgoSr. Executive Regulatory Affairs/ Executive (Finished Formulation)Mahesh Bhupatrai MehtaMumbai(Malad West), Mumbai SuburbanCTDcoordination and communication skills. Proficiency in dossier preparationDossierDmfCTD/ATCD/ CMC/technical review/MOH queries. Strong understanding of regulatory requirements for semi-regulated and non-regulated markets. Excellent documentationCoordinationRegulatoryRequirementsPosted 26 Days AgoRegulatory Executive / Manager - Pharma Co- MumbaiPharmaceutical jobPosted by HRD HouseMumbai (All Areas)OSDRegulatory AffairsDossier PreparationRow MarketCTDDossierActdRegulatory CompliancePharmaceuticalRegulatoryPosted 6 Days AgoSenior Dra ExecutiveAsmoh Laboratories3.6110 reviewsNoida(D Block Sector 63)CTDDossier CompilationActdDrug Regulatory AffairsDossier PreparationRegulatory AffairsFormulationLatamRowRegulatoryDossierDraPosted 9 Days AgoRoles from top companiesSr. Regulatory Affairs OfficerFirm in Pharma & Life Sciences Domain2-7 Yrs3-6 Lacs P.A.AhmedabadHiring for one of these companies1d agoQuality Assurance ManagerFirm in Pharma & Life Sciences Domain11-16 Yrs12-17 Lacs P.A.AhmedabadHiring for one of these companies1d agoRegister to unlockJobs you might be interested inSenior Regulatory Affairs ExecutiveTalish SolutionsPosted by Talish SolutionsAhmedabadPosted 25 Days AgoExecutive - Regulatory & Scientific AffairsNovumgen4.197 reviewsAhmedabad, Vadodara(Vemali)Posted 26 Days AgoAssistant Manager - Regulatory Affairs (Strategy Team)Novumgen4.197 reviewsVadodara(Vemali)Posted 26 Days AgoExecutive - Regulatory AffairsU Square Lifescience3.614 reviewsAhmedabadPosted 17 Days AgoAssistant Manager, Regulatory AffairsAmneal Pharmaceuticals4.21625 reviewsAhmedabadPosted 11 Days AgoReviewsView all13 employee reviews1.0rated by Finance Executive in AhmedabadLikesNothing is likable in this company.Dislikesthis is a worst company I worked in from my all past company. Nothing in this company to like. Toxic finance culture and leadership team is treating employees very badly. If anyone want to ruin their career graph then one can take risk of joining have experience once. all good reviews Posted earlier are fake.Read full reviewPowered bySalary insightsAssistant Manager in Nivagen Pharma (india) typically earns between₹13 - ₹14.4 L/yrSee detailed salary breakupPowered byBenefits & PerksView all2 employees reported these benefitsHealth & Wellness SupportLearning & Development SupportPerformance BonusFree MealTransport / Travel SupportPowered by

Recommended for youKnow moreAI-enhanced profileGet noticed by recruiters by increasing profile views upto 3 timesNaukri Pro builds an AI enhanced profile and keeps it active in searches.

Home Jobs in AhmedabadIEIL has taken all reasonable steps to ensure that information on this site is authentic. Applicants are advised to research bonafides of advertisers independently. IEIL shall not have any responsibility in this regard. We also recommend that you visit Security Guidelines and Terms and Conditions for more comprehensive information on this aspect.Please note that Naukri will not be responsible for any information you share on the company platform.Connect with usAbout usCareersEmployer homeSitemapCreditsHelp centerSummons/NoticesGrievancesReport issuePrivacy policyTerms & conditionsFraud alertTrust & safetyApply on the goGet real-time job updates on our AppAll trademarks are the property of their respective ownersAll rights reserved © 2026 Info Edge (India) Ltd.Our businesses