Submission Publisher
15 hours ago
Job Description Roles & Responsibilities:- - Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision - Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.) - Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ - Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU - Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region - QC submission dossiers or parts of submission dossier output of low-tomoderate and moderate-to-high complexities as assigned.
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Junior Submission Publisher
2 weeks ago
Mumbai, Maharashtra, India sun pharmaceutical ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per yearJob Description Title: Junior Submission Publisher Business Unit: Regulatory Operations Global Regulatory & Business Continuity Innovative Medicines Job Grade: Senior Executive / G11B Location: Mumbai (preferred) / Gurugram / Vadodara Key Responsibilities At Sun Pharma, we commit to helping you Create your own sunshine by fostering an...
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Publishing Coordinator
4 weeks ago
Mumbai, India 1 Finance Full timeResponsibilities: Coordinate end-to-end publishing workflows, from manuscript submission to final production.Collaborate with editorial teams, authors, designers, and vendors to ensure publishing timelines are met.Perform quality checks on content, layouts, and design before release.Assist in preparing content for digital and print distribution, ensuring...
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Regulatory Publisher
7 days ago
Bengaluru, India Indegene Full timeLooking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most...
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Assistant - Regulatory Publishing
1 week ago
Bengaluru, Karnataka, India DXC Technology Full timeSuccessfully meet/ complete training milestones relevant to the position held. - Familiarity with FDA and ICH guidelines, Life Sciences & Pharmaceutical industry - Good knowledge on FDA, GCPs, ICH guidelines, Life Sciences and Pharmaceutical Industry. - Familiarity of health authority procedures / guidance regarding electronic submissions - Perform...
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Publisher
1 week ago
Pune, Maharashtra, India Springer Nature Full time**Key responsibilities**: - Develop and execute the publishing strategy for the journal ensuring alignment with organizational goals and tracking performance through journal targets and development plans. - Work with the team to recruit, onboard, and engage Editorial Board members and Associate Editors. - Build and maintain strong, productive relationships...
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Editorial Submission Advisor
1 day ago
Pune, Maharashtra, India Springer Nature Full time ₹ 15,00,000 - ₹ 28,00,000 per yearJob Title: Editorial Engagement Support AssistantLocation: PuneReports to: Editorial Engagement Support Team LeadAbout Springer Nature GroupSpringer Nature opens the doors to discovery for researchers, educators, clinicians and other professionals. Every day, around the globe, our imprints, books, journals, platforms and technology solutions reach millions...
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Editorial Submission Advisor
7 days ago
Pune, Maharashtra, India Springer Nature Full time**Location**:Pune** **Reports to: Team Lead** **About Springer Nature Group** Springer Nature opens the doors to discovery for researchers, educators, clinicians and other professionals. Every day, around the globe, our imprints, books, journals, platforms and technology solutions reach millions of people. For over 180 years our brands and imprints have...
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Senior Analyst Document Publishing
2 weeks ago
Mumbai, Maharashtra, India Johnson & Johnson Full time ₹ 9,00,000 - ₹ 12,00,000 per yearAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...
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Bengaluru, India Seven Consultancy Full timeJOB DETAILS 1. Capable of planning, strategizing and executing SEO project along with the technical team. 2. Perform exhaustive keyword analysis for the site In depth understanding and experience of On- site Off- site seo. Track the trending white hat techniques for SEO Best practices for dynamic and static WebPages/ Websites. 4. Leverage social...
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Bengaluru, India Genpact Full timeJob Description Ready to shape the future of work At Genpact, we don't just adapt to change-we drive it. AI and digital innovation are redefining industries, and we're leading the charge. Genpact's AI Gigafactory, our industry-first accelerator, is an example of how we're scaling advanced technology solutions to help global enterprises work smarter, grow...