Regulatory Publishing Specialist

5 days ago


Rajkot, Gujarat, India beBeePublishing Full time ₹ 15,00,000 - ₹ 20,00,000

Job Title: Regulatory Publishing Specialist

Key Responsibilities:
  • eCTD Submission Preparation: Prepare and manage submissions in eCTD format using Veeva Vault.
  • Regulatory Document Publication: Compile, format, and publish regulatory documents according to global health authority requirements.
  • Compliance Management: Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.
  • Submission Quality Control: Perform QC of eCTD submissions, including file structure, hyperlinks, and metadata.
  • Cross-Functional Collaboration: Collaborate with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content.
  • Timeline Management: Track submission timelines and deliverables to meet regulatory deadlines.
Required Skills & Qualifications:
  • Veeva Experience: Strong experience in Veeva Vault eCTD Publishing for BLA submissions.
  • Regulatory Knowledge: Knowledge of global regulatory requirements (FDA, EMA).
  • eCTD Sequencing: Hands-on experience in preparing eCTD sequences and publishing ready dossiers.
  • Attention to Detail: Attention to detail with strong organizational skills.
  • Communication Skills: Good communication skills to collaborate with multiple stakeholders.
  • Life Sciences Background: Prior experience in Life Sciences / Pharma regulatory publishing is mandatory.

About the Role

This role requires a skilled Regulatory Publishing Specialist to prepare and manage submissions in eCTD format using Veeva Vault. The ideal candidate will have experience in Veeva Vault eCTD Publishing and knowledge of global regulatory requirements.



  • Rajkot, Gujarat, India beBeeCompliance Full time ₹ 80,00,000 - ₹ 1,50,00,000

    Job Title: Compliance Oversight SpecialistJob DescriptionWe are seeking a skilled Compliance Oversight Specialist to join our team. The ideal candidate will have a strong background in regulatory compliance and experience with risk management.Conduct comprehensive audits and reviews to ensure adherence to regulatory standards.Monitor and implement daily...


  • Rajkot, Gujarat, India beBeeRegulatory Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

    Job OverviewWe are seeking a skilled Regulatory Intelligence Specialist to support the design and deployment of an AI-driven solution for regulatory horizon scanning.The successful candidate will be responsible for continuously monitoring global and regional regulatory bodies for new and updated regulations, consultation papers, and guidance.This role...


  • Rajkot, Gujarat, India beBeeCompliance Full time ₹ 12,00,000 - ₹ 20,00,000

    Job Title: Regulatory Compliance SpecialistAbout the Role:This is a dynamic opportunity for an experienced Regulatory Compliance Specialist to join our team. As a key member of our organization, you will be responsible for ensuring that our business operations comply with all relevant regulatory requirements.We are seeking a highly skilled and knowledgeable...


  • Rajkot, Gujarat, India beBeeRegulatory Full time US$ 90,000 - US$ 1,27,000

    Regulatory Compliance SpecialistJob Overview:We are seeking a detail-oriented Regulatory Compliance Specialist to support global market submissions.Key responsibilities include preparing regulatory documents and evaluating post-approval changes in compliance with international guidelines.Compile initial dossiers for various countries, including US, EU, SA,...


  • Rajkot, Gujarat, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

    Regulatory Affairs ProfessionalAbout the RoleThis key position is responsible for managing and preparing regulatory documents to ensure compliance with international standards.The successful candidate will have a strong understanding of global regulatory guidelines and dossier preparation, allowing them to analyze documents received for product registration...


  • Rajkot, Gujarat, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000

    Job Description:We are seeking a skilled IT Compliance Advisor to join our team. As an IT Compliance Advisor, you will be responsible for ensuring that our systems and processes meet regulatory standards.The successful candidate will have hands-on experience in compliance and validation roles, with a strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and...


  • Rajkot, Gujarat, India beBeeRegulatory Full time ₹ 12,00,000 - ₹ 15,00,000

    The role of Senior Regulatory Affairs Specialist requires strategic leadership in managing the lifecycle of regulatory activities for USFDA submissions.As a key member, you will oversee the preparation, review, and filing of ANDA submissions, Annual Reports, amendments, and deficiency responses. You will collaborate with cross-functional teams to gather...


  • Rajkot, Gujarat, India beBeeCompliance Full time ₹ 20,000 - ₹ 25,000

    Job Title: Compliance OfficerAs a key member of our compliance team, you will play a pivotal role in ensuring effective monitoring and adherence to regulatory requirements across residential child care homes.Key Responsibilities:Conduct daily audits to verify accurate records and safeguarding practices.Review quality reports to ensure alignment with...


  • Rajkot, Gujarat, India beBeeRegulatory Full time ₹ 12,00,000 - ₹ 15,40,000

    Policy and Regulatory Affairs SpecialistThe role of this position is to navigate the regulatory environment, ensuring alignment with business goals. This involves working closely with government bodies, regulatory departments, and stakeholders.Key ResponsibilitiesDevelop and implement strategies to address critical legislative, regulatory, and public policy...


  • Rajkot, Gujarat, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Senior Quality Assurance and Regulatory Affairs SpecialistThis role is responsible for ensuring adherence to quality systems and regulatory frameworks within the medical device industry. The ideal candidate will have a strong understanding of GMP, GDP, ISO 13485 standards, and regulatory submissions.Key Responsibilities:Ensure compliance with ISO 13485, MDD,...