Regulatory Affairs Specialist

Global Regulatory Affairs StrategistKey Responsibilities:Develop and direct global regulatory strategies covering clinical, non-clinical, and CMC aspects.Lead the preparation, review, and approval of submission dossiers for regulatory authorities including US FDA, EMA, Health Canada, Australia's TGA, and ANVISA (Brazil).Provide strategic guidance on...

ResponsibilitiesAs a regulatory affairs officer:ensure that a company's products comply with the regulations of the regions where they want to distribute themkeep up to date with national and international legislation, guidelines and customer practicesrespond to queries from medical bodies like the Medicines and Pertaining to that Guidelines.collect, collate...

Job Overview:As a key member of our Regulatory Affairs team, you will be responsible for the compilation and submission of regulatory documents to various markets, including the US, EU, AU, Canada, IL, and Palestine. You will work closely with stakeholders to review and manage all aspects of dossier compilation, query response, and lifecycle management.About...

Regulatory Affairs SpecialistThis is a key role in ensuring regulatory compliance across various product categories. The successful candidate will be responsible for preparing, reviewing and maintaining regulatory documents to meet international guidelines and country-specific requirements.The role involves close coordination with internal teams and external...

Job TitleExecutive Leader - Business Development and Regulatory Affairs Specialist.Key Responsibilities:Ensure thorough training before executing assigned tasks.Comply with laboratory safety protocols as per established procedures.Execute characterization activities for drug substances and products using analytical techniques like LCMS, GCMS, ICPMS, and ICP...

Preparation of DMFs for different markets in CTD and eCTD formats.Coordination with cross-functional dept to manage the documents.Supporting marketing team & QC/QA/R&D in various capacity.Preparation of Declarations and other supporting docs. Required Candidate profileCandidate from Pharma - API industry and should have 8+ Years of Experience in Regulatory...

Global Regulatory ExpertWe are seeking a highly skilled Global Regulatory Expert to support end-to-end submissions for global markets.This role requires exposure to Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key Responsibilities:Prepare Variation documents and/or evaluate post-approval changes in compliance...

**Job Title:** Medical Affairs StrategistAbout the Role:The General Manager of Medical Affairs will lead medical affairs strategies, providing robust medico-marketing support and facilitating collaboration between medical and marketing teams. This role encompasses the development of medical materials, training programs, and evaluation of new products to...

Company Name: Exemed PharmaceuticalsDesignation - Drug Regulatory Affairs -Officer/Sr OfficerLocation - Vadodara ( Corporate Office)Market: DomesticPrimary Job DescriptionsHaving knowledge of SUGAM portal and CDSCO websiteSubmission for Mfg. & Mkt. Applications [CT21/CT-18] for IND, New Drug, Subsequent New Drug, FDC.Application of CT-05 / CT- 04Application...

Regulatory Affairs AssociateWe are seeking a diligent and experienced Regulatory Affairs professional to support end-to-end submissions for global markets.Key Responsibilities:Prepare variation documents, evaluate post-approval CMC changes, and maintain compliance with global regulatory requirements.Contribute to lifecycle management activities by compiling...