API Regulatory Affairs
1 day ago
Role - API Regulatory Affairs - DMF Filing/ Compilation (Global market)Level - Assistant Manager/Deputy Manager /Associate Manager Level:-Required Education/Exp :-Experience Req.: 7 yrs. - 15 yrs.Qualification: - M.Sc. / M.PharmaResponsibilities1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc.2. Compilation and submission of DMFs globally for small molecule APIs in eCTD format and in-line with ICH and region specific (EU, US, Canada, Japan, Australia, Brazil, China, South Korea etc.) regulatory guidelines.3. Should have good knowledge of all the regulatory guidelines and API Regulatory processes.4. Compilation of response to queries received from Regulatory Agencies & customers globally and submission of response within the stipulated timeline.5. Review and submission of new DMFs, deficiency responses, amendments, updations to various regulatory agencies.6. Evaluation of change controls and updating to agencies by considering change categories.7. Should have hands-on experience in eCTD softwareCandidates with relevant exp., kindly share CVs to apply on :- rashmi.gupta@biocon.comKindly mention below details while sharing CV :-Total Exp?Current CTC?Total number of DMF filings?Handling which major markets globally ?Notice Period?Ready to work in Bangalore (onsite) ? (5 Days working)
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Regulatory Affairs Specialist
1 week 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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Regulatory Affairs Specialist
1 week 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 Executive
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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 specialise in market leading technologies that push the...
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Regulatory Affairs Manager I
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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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Regulatory affairs executive
2 weeks ago
Bangalore, India Halma Plc Full timeHalma 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 specialise in market leading technologies that push the boundaries of...
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Regulatory Affairs Manager- SME
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bangalore, India Mount Talent Consulting Pvt Ltd. Full timeDomain 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...
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Regulatory Affairs Manager- SME
1 week 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
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bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or InjectablesLevel - Deputy Manager/ Associate ManagerRequired Education/Exp:Experience Req.: 8 - 12 yrs.Qualification: - M. Pharma / M.Sc.Key Role- Formulation Regulatory Affairs for Peptide products or InjectablesResponsibilities:Drafting controlled correspondences, pre-development meetings and...
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Regulatory Affairs Specialist
8 hours ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or Injectables Level - Deputy Manager/ Associate Manager Required Education/Ex p: Experience Req.: 8 - 12 yrs. Qualification: - M. Pharma / M.Sc. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Responsibiliti es: Drafting controlled correspondences, pre-development...
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Regulatory Affairs Manager- SME
1 week ago
bangalore district, 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...
