Regulatory Affairs Associate
3 weeks ago
Parexel is seeking a highly skilled Regulatory Affairs Associate to join our team.
Key Responsibilities:
- 4+ years of experience in drug development, especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
- Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging).
- The ability to research and create comparator labeling documents.
- Strong understanding and experience creating annual reports.
- The ability to collaborate with Tech Ops for artwork implementation.
- Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system.
- Electronic document management systems use and/or electronic submission experience.
- Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.
- Must have handled CCDS related submission/safety variations/PSUR/xEVMPD/label and artwork updates.
- Co-ordinate artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs or changes to existing packaging.
- Monitor, manage and control artwork changes.
- To manage and maintain the Artwork Trackers & Systems.
- To ensure artwork PDF's are maintained and latest versions are readily available.
- Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved.
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Regulatory Affairs Associate
3 weeks ago
Mumbai, Maharashtra, India Colgate-Palmolive Company Full timeJob OverviewThis position is responsible for handling and maintaining product compliance throughout the product lifecycle. The Regulatory Affairs Associate will work closely with the Regional Regulatory Affairs Department to ensure compliance with registration and regulatory requirements in Europe and North America.Key ResponsibilitiesSupport the regional...
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Regulatory Affairs Associate
2 weeks ago
Mumbai, Maharashtra, India Colgate-Palmolive Company Full timeColgate-Palmolive is seeking a skilled Regulatory Affairs Associate to join our team. In this role, you will be responsible for handling and maintaining product compliance during the entire product life-cycle.Key Responsibilities:Work closely with the Regional Regulatory Affairs Department to ensure compliance with regulatory requirements.Support the...
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Regulatory Affairs Associate Manager
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Regulatory Affairs Associate
2 weeks ago
Mumbai, Maharashtra, India Colgate-Palmolive Company Full timeJob SummaryThis role is responsible for handling and maintaining product compliance throughout the entire product life-cycle, encompassing various product categories. The successful candidate will report to the Team Lead, Regulatory Operations.Responsibilities:Support the Regional Regulatory Affairs Department in new product registration and life-cycle...
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Regulatory Affairs Associate Manager
3 weeks ago
Mumbai, Maharashtra, India Kenvue Full timeJOB TITLEAssociate Manager, Regulatory AffairsROLE DESCRIPTIONAs a key member of our Regulatory Affairs team at Kenvue, you will play a critical role in ensuring the company's products comply with relevant regulations in the Indian market. This position reports to the Director-Regulatory Affairs and is based in Mumbai.KEY RESPONSIBILITIESDevelop and...
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Regulatory Affairs Associate Manager
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Regulatory Affairs Manager
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Regulatory Affairs Associate Manager
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Mumbai, Maharashtra, India Parexel Full timeAbout this RoleParexel is seeking a highly skilled Senior Regulatory Affairs Associate to join our team in a labeling specialist role. This individual will be responsible for ensuring compliance with key labeling regulations and guidelines.Key ResponsibilitiesCollaborate with cross-functional teams to ensure accurate and compliant labeling.Develop and...
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Regulatory Affairs CMC Manager
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Regulatory Affairs Director
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Mumbai, Maharashtra, India General Mills Full time{"title": "Regulatory Affairs Leader", "sections": [{"title": "Job Overview", "text": "In partnership with our cross-functional partners, ITQ innovates and develops products that meet the ever-changing needs of our consumers and enables long-term business growth. We identify and develop technologies that shape and protect our businesses today and into the...
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Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at 1925 GlaxoSmithKline LLC.About the RoleAs a Regulatory Affairs Specialist, you will be responsible for ensuring the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital...
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