
Regulatory Specialist
3 weeks ago
Accountable to the GRL and Global Regulatory staff for the delivery of Marketing Application pre-approval investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices May be responsible for leadership of relevant submission team for product regulatory authority submission or maintenance activities associated with an approved product including product renewals site registrations renewals variations label harmonization periodic benefit risk evaluation reports PBRER submissions etc May be required to provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets Basic Qualifications Degree in a biological healthcare or scientific discipline or Extensive experience within the drug development environment Awareness of the pharmaceutical industry drug development environment and R D processes and objectives Awareness of Regulatory Affairs responsibilities from pre-IND through Phases I-IV Ability to effectively interact with line and middle management staff and external contacts on a functional and strategic level in a matrix environment Ability to think flexibly in order to meet constantly shifting priorities and timelines Ability to interpret regulations Preferred qualifications Good written and verbal communication skills and ability to present information in a clear and concise manner Excellent organizational skills attention to detail and commitment to deliver high quality output even under pressures sometimes demanded by regulatory deadlines Ability to work flexibility in large teams
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Regulatory Compliance Specialist
10 hours ago
bangalore, India Jupiter AI Labs ✔ Full timeAbout the Role:We are seeking a Regulatory & Compliance Specialist on a contract basis to support our compliance requirements in India and international destination countries. This role is ideal for professionals experienced in handling regulatory filings, certifications, and export-related compliance in pharma, Ayurveda, nutraceuticals, or cosmetics.Key...
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Lead Specialist, Regulatory Affairs
4 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...
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Regulatory affairs specialist
4 weeks ago
Bangalore, India Biocon Biologics Full timeJob Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: • Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio •...
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Regulatory Affairs Specialist
4 days ago
bangalore, India Biocon Biologics Full timeJob Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: • Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio •...
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Regulatory Affairs Specialist
1 week ago
bangalore, India Biocon Biologics Full timeJob Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: • Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio •...
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Bangalore, Karnataka, India GlaxoSmithKline Full timeRegulatory Specialist Submission Coordination works closely with global submission teams Local Operating Company regulatory contacts to deliver end-to-end submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices This role offers an excellent opportunity to develop...
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Regulatory Affairs Specialist
6 days ago
bangalore, India UpMan Placements Full timeCore Job Responsibilities: Regulatory Submissions and compliance Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA Prepare and submit...
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Regulatory Affairs Specialist
6 days ago
bangalore, India UpMan Placements Full timeCore Job Responsibilities:Regulatory Submissions and compliancePrepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDAPrepare and submit...
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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...
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Regulatory Affairs Manager I
2 days ago
Bangalore, Karnataka, India AstraZeneca Full timeJob Title Regulatory Affairs Manager I Global Career Level D1 Introduction to role Are you ready to be part of a team that transforms drug development strategies into reality The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning coordination and execution of assigned...