Syrup Manufacturing Regulatory Affairs Expert

Job Summary:","Regulatory Affairs Specialist: Artwork Management and Compliance"],

Regulatory Affairs Expertise for Drug Manufacturing In this pivotal role, we seek a seasoned Regulatory Affairs Executive to spearhead product registrations with various health authorities. The successful candidate will be responsible for compiling comprehensive Drug Master Files, meticulously preparing and submitting registration dossiers, technical data...

JOB DETAILS 1) Organizing appointments and meetings with Doctor and hospital-based healthcare staff2) Identifying and establishing new business3) Negotiating contracts4) Demonstrating or presenting products to healthcare staff including doctors, nurses and pharmacists5) Undertaking relevantresearch6) Maintaining detailed records7) Attending and organizing...

We are seeking a Regulatory Affairs Executive Freshers To Work in the MNC For Hyderabad LocationThe ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Required Candidate profileB.Pharm & M.Pharm With Knowledge of Regulatory Affairs CTD ECTD DMF and Regulatory Guidelines are...

Job Title: Regulatory Affairs SpecialistAbout This RoleWe are seeking a detail-oriented professional to support end-to-end submissions for global markets, focusing on regulatory affairs - CMC (Chemical, Manufacturing and Controls) aspects.Key ResponsibilitiesPreparing Variation documentsEvaluating post-approval CMC changes in compliance with global...

Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to support end-to-end submissions for global markets.The ideal candidate will possess expertise in Lifecycle Management, Veeva Vault RIM, and complex Initial and Variation submissions.Key ResponsibilitiesPrepare variation documents and/or evaluate post-approval CMC...

Job DescriptionLet's do this. Let's change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by:Driving continuous improvement of processes and...

JOB DETAILS 1.Review all data and documents related to product registrations for various health authoritiesCompilation of Drug Master Files2.Registration Dossiers & Technical Data Packages/OpenParts 3.In-House developed APIs manufactured at In-House API manufacturing sites and ensuring their updation.4.Prepare responses to deficiency letters received from...

Regulatory Affairs Specialist OpportunityWe are seeking a highly skilled Regulatory Affairs professional to support our team in the US market.Key Responsibilities:Prepare and review regulatory submissions, including ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, and PADER in eCTD format.Maintain compliance with US FDA and ICH...

Job Title:Regulatory Affairs Specialist - CMCJob Description:This position involves supporting submissions to regulatory authorities and managing the lifecycle of products. We are seeking a highly skilled Regulatory Affairs Specialist to join our team.Key Responsibilities:Prepare, review, and compile high-quality regulatory submissions in electronic format,...