Regulatory Affairs Specialist

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...

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,...

We're seeking a highly skilled Regulatory Affairs Specialist to join our team. This role combines domain expertise with product leadership, making you the bridge between industry workflows and cutting-edge AI solutions.Key Responsibilities:Provide subject matter expertise in Life Sciences/Pharma/Biotech/MedTech processes, regulations, and workflowsDevelop...

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...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeRegulatory Affairs Specialist In this exciting role as a Regulatory Affair Specialist, you will...

Job SummarySeeking a highly skilled Regulatory Affairs Specialist to prepare, review, and maintain regulatory documents ensuring compliance with international guidelines and country-specific requirements.Key ResponsibilitiesScreen and analyze documents received for product registration requests as per country-specific guidelines.Prepare, compile, and review...

Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to oversee the preparation and submission of regulatory dossiers, ensuring compliance with EU regulations. This role is pivotal in managing activities related to new application submissions through DCP, MRP, NP.This position requires excellent communication skills, both written and...

Job Title:Regulatory Affairs SpecialistWe are seeking an experienced Regulatory Affairs Specialist to oversee the preparation and submission of regulatory dossiers, ensuring compliance and timely approvals in Europe.This role is pivotal in managing activities pertaining to new application submissions for Europe through DCP, MRP, NP.Key...

Job Title:Regulatory Affairs Specialist - CMC StrategyJob Summary:We are seeking a skilled professional to develop and execute CMC regulatory strategies for assigned products, ensuring global compliance.Key Responsibilities:Develop and execute comprehensive CMC regulatory strategies for assigned products across the product lifecycle.Lead the development,...

Regulatory Affairs ProfessionalAbout the Role:We are seeking an experienced Regulatory Affairs professional with a strong background in ANDA submissions and US FDA compliance.Manage the end-to-end preparation and submission of Abbreviated New Drug Applications (ANDAs) and related post-approval submissions including Annual Reports, Complete Response Letters...