Biologics Submission Expert

1 week ago

Varanasi, Uttar Pradesh, India beBeeregulatory Full time ₹ 15,00,000 - ₹ 20,00,000

**Job Title:** Regulatory Publishing Specialist

We are seeking a highly skilled and detail-oriented Regulatory Publishing Specialist to join our team.

Key Responsibilities:
  • Prepare and manage biologics license application (BLA) submissions in electronic common technical document (eCTD) format using Veeva Vault eCTD Publishing.
  • Compile, format, and publish regulatory documents according to global health authority requirements.
  • E nsure compliance with regulatory guidelines (FDA, EMA) and internal processes.
  • Perform quality control 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.

As a Regulatory Publishing Specialist, you will play a critical role in ensuring the success of our regulatory submissions. If you have a passion for detail, excellent communication skills, and experience in Veeva Vault eCTD Publishing, we encourage you to apply.

  • Albumin and Immunoglobulin Production Specialist

    2 weeks ago

    Varanasi, Uttar Pradesh, India beBeeManufacturing Full time ₹ 15,00,000 - ₹ 25,00,000

    Biologics Manufacturing Expert WantedAbout the Role:Develop and scale manufacturing processes for albumin and immunoglobulins.Provide guidance on technology selection, facility setup, and equipment procurement.Ensure compliance with regulatory frameworks, including cGMP, FDA, EMA, DCGI, ICH, and WHO.Support regulatory submissions and strengthen...

  • Biological Research Expert

    4 days ago

    Varanasi, Uttar Pradesh, India beBeeBiology Full time US$ 45,000 - US$ 75,000

    Unlocking the Secrets of Biology:We are seeking experienced researchers in biology to contribute to our cutting-edge research projects.As a researcher, you will be responsible for creating complex biology problems, analyzing model responses, and identifying gaps in logic or understanding.The goal is to measure how well our models handle abstract thinking and...

  • Academic Content Expert- Biology in Varanasi

    1 week ago

    Varanasi, Uttar Pradesh, India QA Solvers Inc. Full time ₹ 6,00,000 - ₹ 8,00,000 per year

    Key ResponsibilitiesAct as a Subject Matter Expert (SME) in Biology to create and review academic content under the Alt Text project.Develop accurate and accessible biology content aligned with educational standards and the goals of the Alt Text initiative.Review and edit biology-related study materials for grammar, structure, and scientific...

  • Senior Bioinformatics Specialist

    5 days ago

    Varanasi, Uttar Pradesh, India beBeeBioinformatics Full time ₹ 18,00,000 - ₹ 21,00,000

    About the Opportunity:We are seeking an experienced Senior Bioinformatics Specialist to join our team. The ideal candidate will bring a strong background in clinical bioinformatics, with hands-on experience in processing and analyzing omics data.Key Responsibilities:Analyzing multi-omics biological data to derive relevant insights using state-of-the-art...

  • Senior Tax Expert

    6 days ago

    Varanasi, Uttar Pradesh, India beBeeTax Full time ₹ 8,00,000 - ₹ 10,00,000

    Job Title: Senior Tax ExpertThis is a high-profile role that requires collaboration with tax authorities, coordination of ongoing matters, and preparation of rectification applications and related submissions.Key ResponsibilitiesSupport tax authorities during assessment proceedings.Liaise with tax authorities on various matters.Draft and submit rectification...

  • Financial Expert

    5 days ago

    Varanasi, Uttar Pradesh, India beBeeFinancial Full time US$ 50,000 - US$ 75,000

    Job Title: Financial Expert We are seeking a highly skilled and experienced financial professional to join our team.About the Role:The ideal candidate will have solid experience in the real estate and construction industry, with proven expertise in RERA submissions, project-based accounting, taxation, and statutory compliance.Key Responsibilities:To manage...

  • Expert BIM Professional

    6 days ago

    Varanasi, Uttar Pradesh, India beBeeBim Full time ₹ 50,00,000 - ₹ 1,00,00,000

    Job Title: BIM ExpertAre you a skilled BIM modeler looking for a challenging role? We have an exciting opportunity for a talented individual to join our team as a BIM Expert.Job Description:As a BIM Expert, you will be responsible for supporting the Discipline Lead and BIM Manager in day-to-day BIM implementation activities. This includes maintaining records...

  • Invoicing Expert

    6 days ago

    Varanasi, Uttar Pradesh, India beBeeInvoicing Full time ₹ 6,00,000 - ₹ 12,00,000

    As a skilled Invoicing Specialist, you will play a key role in maintaining financial accuracy by ensuring timely and precise invoicing.About the Role:We are seeking an Invoicing Specialist to prepare and issue invoices to customers, meet delivery timelines and understand key areas of invoicing specific to each customer.Key Responsibilities:Prepare and issue...

  • Procurement Expert

    2 weeks ago

    Varanasi, Uttar Pradesh, India beBeeTender Full time ₹ 5,00,000 - ₹ 12,34,567

    Tender SpecialistJob Summary:We are seeking a skilled Tender Specialist to join our team. As a key member of our procurement function, you will play a critical role in the development and execution of technical and commercial bid documents.Develop and execute Technical & Commercial Bid documents in accordance with specifications.Manage Digital Signature...

  • Dam Break Response Expert

    1 week ago

    Varanasi, Uttar Pradesh, India beBeeDamBreakAnalysis Full time ₹ 11,00,000 - ₹ 24,79,000

    Job Title:Specialist in Dam Break Analysis and Emergency PlanningSeeking a qualified Dam Break Analysis Specialist with expertise in hydrological and hydraulic modeling using advanced tools like MIKE, HEC-HMS, or others. Proficient in flood routing, dam break analysis, inundation mapping, and operational protocols of dams using mathematical models for...