
Regulatory Publishing Professional
4 days ago
Job Summary
We are seeking a highly skilled and experienced Regulatory Publishing Specialist to join our team. In this role, you will be responsible for preparing and managing Biologics License Applications (BLA) in Electronic Common Technical Document (eCTD) format using Veeva Vault eCTD Publishing.
Key Responsibilities:
- eCTD Publishing: Prepare and manage BLA submissions in eCTD format using Veeva Vault eCTD Publishing, ensuring compliance with global health authority requirements.
- Regulatory Compliance: Maintain compliance with regulatory guidelines and internal processes, performing quality control of eCTD submissions, including file structure, hyperlinks, and metadata.
- Collaboration: Collaborate with cross-functional teams to gather and manage content, track submission timelines, and deliverables to meet regulatory deadlines.
Required Skills & Qualifications:
- Veeva Expertise: Expertise in Veeva Vault eCTD Publishing for BLA submissions is essential.
- Regulatory Knowledge: Familiarity with global regulatory requirements is necessary.
- eCTD Sequencing: Hands-on experience in preparing eCTD sequences and publishing ready dossiers is required.
- Attention to Detail: Strong organizational skills and attention to detail are crucial.
- Communication: Effective communication skills to collaborate with multiple stakeholders are essential.
- Lifecycle Experience: Prior experience in Life Sciences / Pharma regulatory publishing is preferred.
-
Senior Regulatory Publishing Professional
1 week ago
Coimbatore, Tamil Nadu, India beBeePublishing Full time ₹ 60,00,000 - ₹ 80,00,000Regulatory Publishing SpecialistJob Description:The Regulatory Publishing Specialist will be responsible for preparing and managing Biologics License Application (BLA) submissions in electronic Common Technical Document (eCTD) format using Veeva Vault eCTD Publishing.Key Responsibilities:Prepare and manage BLA submissions in eCTD format using Veeva Vault...
-
Publishing Operations Specialist
2 weeks ago
Coimbatore, Tamil Nadu, India beBeePublishing Full time ₹ 9,00,000 - ₹ 12,00,000Job Overview:Oversee end-to-end publishing processes, ensuring seamless collaboration between editorial teams, authors, designers, and vendors.Key Responsibilities:Publishing WorkflowsCoordinate manuscript submission to final production, meeting publishing timelines.Perform quality checks on content, layouts, and design before release.Content...
-
Regulatory Oversight Professional
7 days ago
Coimbatore, Tamil Nadu, India beBeeRegulatory Full time ₹ 1,00,00,000 - ₹ 1,50,00,000At Vahura, we are seeking a skilled professional to join our global team. This exciting opportunity involves managing regulatory affairs, overseeing compliance issues, and producing reports for senior management.Key Responsibilities:Manage and coordinate regulatory examinations (logging information requests, preparing presentations, reviewing...
-
Publisher Yield Manager
1 week ago
Coimbatore, Tamil Nadu, India InvestingChannel Full timeAbout Us:InvestingChannel (IC) is one of the most innovative online financial marketing platforms reaching an audience of 20 million influential decision makers who are affluent and engaged and span the complete finance spectrum including Individual Investors, Active Traders, Financial Advisors, Institutional Investors and more. InvestingChannel empowers the...
-
Regulatory Compliance Professional
7 days ago
Coimbatore, Tamil Nadu, India beBeeCompliance Full time ₹ 17,46,300 - ₹ 24,69,100Our organization is seeking a highly skilled Regulatory Compliance Professional to oversee the implementation and management of our IT Governance, Risk and Compliance (GRC) framework.This role requires a deep understanding of the ever-evolving regulatory landscape and the ability to analyze and translate laws, regulations and technical requirements into...
-
Publishing Support Specialist
7 days ago
Coimbatore, Tamil Nadu, India beBeeCustomer Full time ₹ 6,00,000 - ₹ 8,00,000Job DescriptionWe are a rapidly expanding SaaS product empowering aspiring authors to publish their work with ease.This role is crucial in supporting our users while helping grow the platform through user insights and upselling opportunities.Key Responsibilities:Assist platform users by addressing their queries and concerns via email and phone calls,...
-
Desktop Publishing Expert
5 days ago
Coimbatore, Tamil Nadu, India beBeePublication Full time ₹ 9,00,000 - ₹ 12,00,000Job SummaryA Desktop Publishing Specialist is required to work from home on a night shift job, Monday to Friday.This position involves formatting and proofreading documents in various languages for healthcare projects.Key Responsibilities:Proficient in using Adobe Creative Suite including InDesign, Illustrator, Photoshop, MS Word, and PowerPoint.Familiarity...
-
Regulatory Compliance Professional
7 days ago
Coimbatore, Tamil Nadu, India beBeeCompliance Full time ₹ 16,43,203 - ₹ 24,39,364Job Role Summary:The Compliance Manager is responsible for maintaining the company's regulatory compliance framework and governance structure.Understanding of Peak margin, Quarterly settlement, MTF, CUSIP process to address queries/alerts from exchanges.Audits mandated by NSE and BSE handling and implementation of latest circulars issued by...
-
Senior Power Regulatory Advisor
1 week ago
Coimbatore, Tamil Nadu, India beBeeRegulatory Full time ₹ 36,00,000 - ₹ 40,00,000Regulatory Expert SoughtWe are on the hunt for a seasoned Regulatory Specialist with extensive expertise in the power sector.The ideal candidate will be responsible for handling regulatory filings, tariff determination, and compliance with regulatory frameworks.The successful professional should have a proven track record of working with Regulatory...
-
Medical Devices Regulatory Specialist
2 weeks ago
Coimbatore, Tamil Nadu, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 20,00,000Regulatory Affairs Manager Job DescriptionWe are seeking an experienced Regulatory Affairs Manager to join our team. The ideal candidate will have a strong understanding of quality systems and regulatory frameworks.Key Responsibilities:Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.Coordinate with local authorities for obtaining...