Regulatory Affairs Manager- SME
2 days ago
Domain lead - SME - Safety and Regulatory - BA offshoreExpert in Pharma domain’s multiple functions especially Regulatory and SafetyWell versed with business functions and tools used by industryAble to create integrated solutions and able to address customer pain pointsAble to draw process flowsAct as Technical Product Owner for global regulatory systems and solutions, ensuring alignment with business goals and compliance requirements.Gather, analyze, and document business requirements from regulatory stakeholders across global regions, ensuring clarity and completeness.Facilitate workshops, requirement-gathering sessions, and backlog groomingDrive solution design discussions, ensuring integration with existing regulatory, safety and submission management platforms.Ensure adherence to pharmaceutical regulatory frameworks (e.g., FDA, EMA, ICH) and compliance with data integrity and GxP standards.Have knowledge of FDA, EMA and other agency’s rules and regulationsProvide thought leadership on digital tools and process optimization in the global regulatory affairs space as well as Safety signal identification and assessment.Be the go-to person for customers and Account team for any functional knowledge on Regulatory and SafetyHave 10+ years of relevant experience
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Regulatory Affairs Manager- SME
1 day ago
Bangalore, India Mount Talent Consulting Pvt Ltd. Full timeDomain lead - SME - Safety and Regulatory - BA offshore Expert in Pharma domain’s multiple functions especially Regulatory and Safety Well versed with business functions and tools used by industry Able to create integrated solutions and able to address customer pain points Able to draw process flows Act as Technical Product Owner for global regulatory...
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Regulatory Affairs Specialist
3 days ago
bangalore, India Concept Medical Full timeAbout Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...
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Regulatory Affairs Manager I
3 weeks 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...
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Senior Manager Regulatory Affairs
16 hours ago
bangalore, India One of the Leading Surgical solutions and Medtech Company Full timeOur client is one one of the pioneers and trusted surgical solutions and medtech companies. They export to more than 80 countries worldwide and collaborate with hospitals, governments, and healthcare systems worldwide to strengthen surgical ecosystems and improve patient lives.Primary Role: The QA & Regulatory Affairs Manager leads and oversees all...
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Regulatory Affairs Executive
2 weeks ago
bangalore, India Halma plc Full timeAbout Halma:Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
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Regulatory Affairs Specialist
2 days ago
bangalore, India Dr. Reddy's Laboratories Full timeJob SummaryWe are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...
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Regulatory Affairs Executive
2 weeks ago
Bangalore, India Halma plc Full timeAbout Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
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Regulatory Affairs Executive
2 weeks ago
bangalore, India Halma plc Full timeAbout Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
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Regulatory Affairs Executive
2 weeks ago
Bangalore, India Halma plc Full timeAbout Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
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Scientific and Regulatory Affairs Consultant
2 weeks ago
Bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or Injectables Required Education/Ex p: Experience Req.: 8 - 12 yrs. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Drafting controlled correspondences, pre-development meetings and scientific advices for seeking regulatory feedback on various topics from different...
