Regulatory Publishing Professional – eCTD Expert

Regulatory Affairs PositionManage regulatory submissions, including new drug applications (NDAs), complete response letters (CRLs), information requests (IRs), and amendments to existing NDAs.File post-approval and prior approval supplements in compliance with FDA regulations.Review change controls to assess their impact on regulatory alignment and ensure...

Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other domestic markets. Support product development, registration, & lifecycle management in Europe Manage Regulatory Compliance & Approvals Required Candidate profileMinimum 4 years of exp in Formulation OSD Willing to work in Chennai3.Strong expertise in EU,...

Book Publishing ProfessionalDemocratizing publishing and empowering writers to reach readers worldwide is our driving passion.Job Description:As a Book Publishing Professional, you will play a pivotal role in understanding the needs of authors and providing effective solutions. You will manage relationships with authors, guide them in their marketing and...

Regulatory Submission Expert Job Description: As a Regulatory Affairs professional, you will play a crucial role in ensuring the successful submission of regulatory documents for pharmaceutical products. This includes preparing and reviewing new ANDA filings, amendments, and Annual reports to the ANDA. Key Responsibilities: 1. Prepare and review regulatory...

JOB DETAILS Manages, reviews, and authors regulatory submissions, including new ANDA filings, complete response letters (CRLs), information requests (IRs), and amendments to existing ANDAs.Responsible for filing Post-Approval and Prior Approval Supplements in compliance with FDA requirements.Reviews change controls to assess regulatory impact and ensure...

Job TitleWe are seeking a highly skilled professional to join our team as a Regulatory Expert in the Power Sector.The ideal candidate will have a strong background in regulatory matters, with experience in financial and tariff modeling specific to the power sector.Develop and implement strategies to stay updated on energy policies, regulations, and...

Regulatory Expert WantedWe are seeking an experienced Regulatory Specialist with strong expertise in the power sector to lead our regulatory initiatives.About This RoleThe ideal candidate will be responsible for handling ARR filings, tariff determination, petitions, and compliance with regulatory frameworks.Manage ARR filings, tariff determination, and...

Job TitleA regulatory professional is sought to manage and coordinate examinations, oversee regulatory issues and action plans, and produce insightful reporting and metrics. This role offers a unique opportunity to work with a dynamic global team that oversees supervisory activities of regulators across regions.This position involves managing examination...

Regulatory Affairs SpecialistThis is a key role within our organization, responsible for ensuring compliance with regulatory requirements. The Regulatory Affairs Specialist will work closely with cross-functional teams to prepare and submit amendments and supplements for assigned products.Key Responsibilities:Amendment and Supplement Preparation: Prepare,...

Publishing Administrative CoordinatorWould you enjoy providing business support to a busy publishing teamWould you enjoy delivering effective administration services that make a difference to our successAbout the BusinessA global leader in information and analytics we help researchers and healthcare professionals advance science and improve health outcomes...