Regulatory Affairs Specialist
5 days ago
About UsefulBI:UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services.Role Overview:We are seeking a Regulatory Affairs Subject Matter Expert (SME) with 5–8 years of experience in the pharmaceutical or life sciences industry. The ideal candidate will provide strategic and operational expertise in global and regional regulatory requirements and submissions. This role involves collaborating with cross-functional teams across clinical, CMC, medical, and quality functions to ensure compliance with health authority regulations.Key Responsibilities:- Provide subject matter expertise in global and regional regulatory requirements and submissions.- Review and interpret regulatory guidelines to support product development and lifecycle management.- Partner with cross-functional teams (clinical, CMC, medical, and quality) to ensure compliance with applicable regulations.- Prepare, review, and maintain regulatory documents including INDs, NDAs, MAAs, CTDs, and other agency submissions.- Support responses to health authority queries and regulatory audits.- Track and implement changes in regulatory frameworks impacting ongoing and future submissions.Required Skills:- Strong understanding of global regulatory processes (USFDA, EMA, CDSCO, etc.).- Hands-on experience with eCTD submissions and regulatory strategy development.- Excellent analytical, documentation, and communication skills.
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Global Regulatory Affairs Lead
2 weeks ago
bangalore, India beBeeregulatory Full timeRegulatory Affairs Specialist OpportunityWe are seeking a highly skilled Regulatory Affairs Specialist to join our team.This role will involve managing regulatory submissions across multiple countries.The successful candidate will have strong expertise in dossier preparation and submission, as well as excellent communication and coordination skills.You will...
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Chief Regulatory Affairs Specialist
2 days ago
bangalore, India beBeeRegulatoryAffairs Full timeRegulatory Affairs Expertise:As a key member of our organization, you will be responsible for the authoring, compilation, and submission of regulatory dossiers to global health authorities.Conduct thorough dossier gap analyses to identify document and data gaps.Prepare and convert dossiers in various formats to meet regulatory requirements.Manage the...
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Regulatory Affairs Specialist
4 days ago
bangalore, India UsefulBI Corporation Full timeAbout UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services. Role Overview: We are seeking a Regulatory Affairs Subject Matter...
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Regulatory Affairs Manager
3 weeks ago
bangalore, India Ixoreal Biomed Full timeAbout the Company: Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts. Title: Manager/Senior Manager- Global Regulatory Affairs Experience: 8–12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements,...
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Regulatory Affairs Associate
3 weeks ago
Bangalore, Karnataka, India Anrgi Tech Full timeJob Title Regulatory Affairs Associate - Authoring Role detailed classification Regulatory Affairs Authoring Job Summary We are seeking highly skilled and experienced Life Sciences LS Regulatory Affairs RA Associate - Authoring to join our LS Practice team The successful candidate will be responsible for LS Regulatory Authoring and or other assigned RA...
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Regulatory Affairs Analyst
4 weeks ago
bangalore, India Varex Imaging Corporation Full timeVarex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the following:...
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International Regulatory Affairs Manager I
4 weeks ago
Bangalore, Karnataka, India AstraZeneca Full timeJob Title International Regulatory Affairs Manager I Global Career Level D1 Introduction to role Within International Regulatory Affairs we take innovative regulatory approaches to bring life-changing medicines to patients in international markets We work across the AstraZeneca pipeline and business to accelerate regulatory approvals for new medicines in...
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Regulatory Affairs Analyst Ii
4 weeks ago
Bangalore, Karnataka, India Waters Full timeOverview The Regulatory Affairs Specialist II has primary responsibility for provision of In Vitro Diagnostic regulatory support to prepare execute and maintain regulatory filings including change management support of post market requirements and support of outside vendors e g license holders in country representatives Secondary responsibility would be to...
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Lead Specialist, Regulatory Affairs
3 weeks ago
Bangalore, Karnataka, India GE Healthcare Full timeSummary Join GE HealthCare as a Lead Specialist in Regulatory Affairs and play a pivotal role in shaping the future of medical imaging This global leadership position offers the opportunity to drive regulatory strategies and lead cross-functional teams to bring innovative X-ray imaging products to market Be part of a dynamic environment where your expertise...
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Associate Staff Regulatory Affairs Specialist
3 weeks ago
Bangalore, Karnataka, India BD Full timeSummary This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance This position participates on cross-functional teams leads the development of global regulatory strategies authors regulatory submissions leads interactions with regulatory agencies notified bodies reviews design control...