
Regulatory Document Specialist
7 hours ago
Job Description
We are seeking an experienced Regulatory Publishing Specialist to join our organization.
Main Responsibilities:
- Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing.
- Compile, format, and publish regulatory documents according to global health authority requirements.
- Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.
- Perform QC of eCTD submissions, including file structure, hyperlinks, and metadata.
- Collaborate with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content.
- Track submission timelines and deliverables to meet regulatory deadlines.
Required Skills & Qualifications:
- Strong experience in Veeva Vault eCTD Publishing for BLA submissions.
- Knowledge of global regulatory requirements (FDA, EMA).
- Hands-on experience in preparing eCTD sequences and publishing ready dossiers.
- Attention to detail with strong organizational skills.
- Good communication skills to collaborate with multiple stakeholders.
- Prior experience in Life Sciences / Pharma regulatory publishing is mandatory.
-
Technical Documentation Specialist
5 days ago
Thāne, Maharashtra, India beBeeDocumentation Full time ₹ 8,00,000 - ₹ 13,00,000Documentation SpecialistRole Overview:Our organization seeks a skilled documentation specialist to develop, maintain and deliver high-quality documentation for life sciences products.Key Responsibilities:Create user-centric content including IFUs, user manuals, product labels, and digital learning aids.Translate complex scientific/regulatory information into...
-
Regulatory Compliance Specialist
4 days ago
Thāne, Maharashtra, India beBeeRegulatory Full time ₹ 1,80,07,440 - ₹ 2,11,11,600Job Title: Regulatory Compliance SpecialistJob Summary:This is a dynamic position requiring a seasoned professional with a deep understanding of quality systems and regulatory frameworks for medical devices.About the Role:We are seeking a highly skilled individual to ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements by implementing...
-
Financial Documentation Specialist
1 day ago
Thāne, Maharashtra, India beBeeDocument Full time ₹ 15,00,000 - ₹ 28,00,000Job Title: Financial Documentation SpecialistPrepare and verify documentation related to working capital loans, ensuring all required paperwork is complete and accurate.Coordinate with clients and internal teams to collect necessary documents for loan processing and approval.Ensure compliance with regulatory requirements and company policies during...
-
Export Import Documentation Specialist
7 days ago
Thāne, Maharashtra, India beBeeDocumentationspecialist Full time ₹ 30,00,000 - ₹ 40,00,000Job Overview">We are seeking a skilled Export Import Documentation Specialist to join our team. In this role, you will be responsible for coordinating the documentation process for export and import transactions, ensuring compliance with relevant regulations and policies.">Responsibilities">"> Coordinate with suppliers and customers to obtain necessary...
-
Regulatory Specialist
3 days ago
Thāne, Maharashtra, India beBeeLawyer Full time ₹ 40,00,000 - ₹ 80,00,000About Genomics Roles:Genomics is a rapidly evolving field that utilizes DNA sequencing to improve human health. We build applications that leverage genetic data to drive groundbreaking research and innovative solutions.In this role, you will be responsible for reviewing and preparing statutory documents, ensuring compliance with regulatory requirements. You...
-
Legal Associate Intern
2 days ago
Thāne, Maharashtra, India World Legal Regulatory Council Full time ₹ 3,000 - ₹ 4,000 per yearJob Title: Legal InternCompany:World Legal Regulatory Council (WLRC)Position Type:Internship (3 months)Location:RemoteWorking Hours:Monday - SaturdayInternship OverviewTheWorld Legal Regulatory Council (WLRC)is seeking adedicated and proactive Legal Internto support its legal and regulatory operations. This internship is an opportunity to gain hands-on...
-
Regulatory Affairs Specialist
7 days ago
Thāne, Maharashtra, India Bayer Full time US$ 90,000 - US$ 1,20,000 per yearAt Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...
-
Regulatory Affairs Expert
5 days ago
Thāne, Maharashtra, India beBeeCompliance Full time US$ 60,000 - US$ 85,000Business Compliance SpecialistThis role involves handling federal registrations, state and local tax registrations, payroll setups, and managing ongoing regulatory compliance in the USA.Assist clients with business entity formations, including LLCs, corporations, partnerships, and sole proprietorships.Manage federal business registrations, including...
-
Regulatory Affairs Specialist
2 days ago
Thāne, Maharashtra, India Bayer Full time US$ 90,000 - US$ 1,20,000 per yearAt Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...
-
Product Documentation Specialist
7 hours ago
Thāne, Maharashtra, India beBeeDocumentation Full time ₹ 20,00,000 - ₹ 30,00,000Product Documentation SpecialistWe seek a seasoned technical writer to create and maintain product documentation in the networking, telecom, or contact center domains. The ideal candidate should have 8+ years of experience in technical writing within these fields.