Regulatory Specialist
15 hours 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 Affairs Specialist
2 weeks ago
bangalore, India Biocon Biologics Full timePosition Summary The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...
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Lead Specialist, Regulatory Affairs
1 week 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 Compliance Specialist
2 days 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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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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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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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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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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Regulatory Specialist and Senior 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. Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio • Coordination of...
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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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International Regulatory Affairs Manager I
2 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...
