Global Regulatory Submission Specialist
2 weeks ago
Regulatory Affairs ExpertAbout the Role:We are seeking an accomplished Regulatory Affairs Specialist to lead our global submissions.Author, compile, and submit regulatory dossiers to health authorities worldwide.Conduct thorough dossier gap analysis to identify document and data gaps across all CTD modules.Prepare dossiers in multiple formats including eCTD, ACTD, and CTD.Manage end-to-end preparation and submission of lifecycle documents.Coordinate responses to health authority queries through cross-functional collaboration and data collation.Key Responsibilities:Lead regulatory submissions for multiple products across multiple countries simultaneously.Utilize project management tools to track project milestones, timelines, and deliverables.Ensure efficient time and resource allocation to meet submission deadlines.Foster seamless communication between regulatory teams and stakeholders.Requirements:8–10 years of core experience in Regulatory Affairs, handling submissions globally.Strong understanding of global dossier formats and submission pathways.Excellent cross-functional communication and coordination skills.Proven ability to manage complex regulatory portfolios.
-
EU Packaging Regulatory Specialist
2 weeks ago
palakkad, India beBeePackaging Full timeThe role of a EU Packaging Regulatory Specialist entails translating complex regulations into actionable insights to facilitate global companies' understanding of their PPWR obligations.Main responsibilities involve analyzing EU and national packaging legislations, interpreting regulatory requirements to inform practical workflows, evaluating packaging...
-
Regulatory Medical Content Specialist
2 days ago
palakkad, India beBeeMedical Full timeRegulatory Medical Content SpecialistThe Role:As a Regulatory Medical Content Specialist, you will be responsible for creating high-quality scientific communication that adheres to regulatory guidelines. Your primary goal is to ensure the accuracy and integrity of clinical study reports, investigator brochures, and other critical documents.Drafting,...
-
Global Lead Statistical Programmer
7 days ago
palakkad, India SUN PHARMA Full timeGrade: Manager Location: Hybrid at Gurugram/Mumbai. 100% Remote for the right candidate. Job Purpose Lead one or more Phase I-IV studies programming activities as per the project strategies. Work independently implementing and executing the programming and project standards to support ongoing clinical studies and requests for study report, regulatory...
-
Entity Regulatory Specialist
6 days ago
palakkad, India beBeeCompliance Full timeJob Opportunity:We are seeking an experienced Compliance Professional to ensure all entities within our organization remain compliant with relevant laws and regulations.The ideal candidate will have 0-3 years of experience in corporate secretarial compliances, human resources, and employment laws.Ensure compliance with regulatory requirements, including...
-
Procurement Specialist
1 week ago
palakkad, India beBeeSourcing Full timeProcurement Specialist - Global SourcingSourcing Manager for NPD/AD/CPD ProjectsKey Responsibilities:We are seeking a seasoned direct purchasing and global sourcing expert to drive end-to-end NPD sourcing, cost engineering, and supplier development across global programs. This role will be responsible for leading sourcing for NPD/AD/CPD projects from RFQ to...
-
Senior Regulatory Compliance Specialist
2 days ago
palakkad, India beBeeRegulatory Full timeSafety Data Sheet SpecialistIn this role, you will be responsible for creating and maintaining regulatory-compliant Safety Data Sheets (SDS) for international customers. Your primary function will be to cost-effectively prepare SDS documents that meet the requirements of various countries, including the US, EU, Canada, and others.Key Responsibilities:Author...
-
IT Project Acquisition Specialist
3 days ago
palakkad, India beBeeAcquisition Full timeIT Project Acquisition SpecialistWe are seeking a skilled professional to join our team as an IT Project Acquisition Specialist. This role is ideal for individuals with strong connections in the IT industry and an understanding of global technology trends.The successful candidate will work closely with our leadership team to identify, source, and bring new...
-
Global Technical Support Specialist
2 weeks ago
palakkad, India beBeeGlobal Full timeTechnical Support Role OverviewWe are hiring multiple technical support specialists to provide assistance on a global scale. These freelance positions require professionals who excel at troubleshooting, customer interaction, application support, and technical analysis across various environments.Type: Independent Freelance ConsultantLocation: 100%...
-
Global Community Liaison
2 weeks ago
palakkad, India beBeeCommunications Full timeJob OverviewThe role of Communications Specialist entails supporting a 24/7 team, focusing on creating and managing community posts for a global audience. Key responsibilities include crafting compelling content to engage diverse stakeholders, collaborating with cross-functional teams, and ensuring consistency across all communication channels.Key...
-
Data Analyst Developer
2 weeks ago
palakkad, India beBeeData Full timeJob OverviewThis role is a key contributor to the development of analytical outputs for clinical trials.As a Statistical Programmer, you will work closely with statisticians, data managers, and clinical teams to ensure timely and quality delivery of programming outputs.Key Responsibilities:Develop ADaM datasets, TLFs, and other analytical outputs for...