Regulatory Publishing Expert for eCTD Submissions

5 days ago

Guntur, Andhra Pradesh, India beBeePublishing Full time ₹ 40,00,000 - ₹ 60,00,000

Job Summary:

We are seeking a Regulatory Publishing Expert to join our team and support the preparation and management of BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing.

The ideal candidate will have strong experience in Veeva Vault eCTD Publishing for BLA submissions, knowledge of global regulatory requirements, and hands-on experience in preparing eCTD sequences and publishing ready dossiers.

Key Responsibilities:

  • Prepare and manage BLA 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 and internal processes.
  • Perform QC of eCTD submissions, including file structure, hyperlinks, and metadata.
  • Collaborate with cross-functional teams 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.
  • 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.

Benefits:

  • Opportunity to work with a leading company in the industry.
  • Collaborative and dynamic work environment.
  • Professional development and growth opportunities.

Others:

Please note that we do not disclose company budget information. If you are interested in this opportunity, please submit your application.

  • Power Sector Regulatory Expert

    3 days ago

    Guntur, Andhra Pradesh, India beBeeRegulatory Full time ₹ 36,00,000 - ₹ 40,00,000

    Job OverviewA seasoned Regulatory Expert with a strong understanding of the power sector is sought after by our client. The ideal candidate will have a proven track record of working with regulatory bodies and providing end-to-end support in regulatory submissions.Key Responsibilities:Handling rate filings, tariff determination, petitions, and compliance...

  • Detail-Oriented Regulatory Expert

    3 days ago

    Guntur, Andhra Pradesh, India beBeeRegulatoryAffairs Full time ₹ 10,00,000 - ₹ 15,00,000

    Regulatory Affairs AssociateWe are seeking a detail-oriented professional to support end-to-end submissions for global markets.The ideal candidate will have experience in managing initial submissions, variations, and full lifecycle management deliverables for the global markets.Key Responsibilities:Prepare variation documents and/or evaluate post-approval...

  • Senior Financial Regulatory Expert

    1 week ago

    Guntur, Andhra Pradesh, India beBeeFinancial Full time ₹ 1,80,00,000 - ₹ 2,40,00,000

    Job Title: Senior Financial Regulatory ExpertWe are seeking a highly skilled and experienced Senior Financial Regulatory Expert to join our team.About the RoleThis is a senior role within our Financial Regulatory Practice, responsible for steering complex client engagements across regulatory supervision, policy formulation, risk management, and compliance...

  • Global Regulatory Compliance Specialist

    1 week ago

    Guntur, Andhra Pradesh, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000

    Regulatory Affairs Expert RoleJob Summary:We are seeking a seasoned Regulatory Affairs professional with in-depth knowledge of pharmaceutical and medical device regulatory compliance.Key Responsibilities:Develop, review, and submit high-quality regulatory filings to global health authorities, ensuring adherence to applicable regulations.Maintain expert...

  • Regulatory Operations Specialist

    2 days ago

    Guntur, Andhra Pradesh, India beBeeRegulatory Full time ₹ 1,00,00,000 - ₹ 2,00,00,000

    Job Title: Regulatory Operations SpecialistWe are seeking a detail-oriented and experienced Regulatory Reporting professional to join our team.Key Responsibilities:Conduct comprehensive product audits and compliance checks to ensure adherence to regulatory standards.Monitor and implement daily regulatory compliance requirements.Develop and maintain robust...

  • Regulatory Affairs Expert Lead

    3 days ago

    Guntur, Andhra Pradesh, India beBeeExpertise Full time ₹ 80,00,000 - ₹ 1,50,00,000

    Product Stewardship is seeking a skilled Regulatory Affairs Expert Lead to ensure market compliance across EMEA territories.The role will involve:Developing and managing substance registration projects in line with global registration strategiesPlanning, preparing, and submitting substance registration dossiers under REACH regulationsAdvising on potential...

  • Regulatory Compliance Specialist

    3 days ago

    Guntur, Andhra Pradesh, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000

    Compliance Officer Job DescriptionWe are seeking a highly skilled Compliance Officer to join our team. The successful candidate will play a vital role in ensuring the company's regulatory submissions are completed accurately and on time.Key Responsibilities:Upload regulatory submissions to the portal after obtaining concurrence from relevant...

  • Drive Brand Visibility Through Impactful Award Submissions

    2 days ago

    Guntur, Andhra Pradesh, India beBeeGovernmentGrants Full time ₹ 80,00,000 - ₹ 1,20,00,000

    Unlock Strategic Growth Opportunities as a Government Grants SpecialistAbout the Role:You will drive brand visibility through impactful award submissions while identifying and leveraging government policies, schemes, and certifications that align with our objectives.This cross-functional role is perfect for someone who thrives on writing, building...

  • Regulatory Affairs Specialist

    1 day ago

    Guntur, Andhra Pradesh, India beBeeRegulatoryAffairs Full time ₹ 16,20,000 - ₹ 21,60,000

    Job Overview:We are seeking a detail-oriented and organized professional with expertise in regulatory affairs to support the preparation, review, and maintenance of regulatory documents.The ideal candidate will have a strong understanding of global regulatory guidelines, excellent organizational and analytical skills, and experience in dossier compilation,...

  • Experienced Legal Expert Wanted

    2 weeks ago

    Guntur, Andhra Pradesh, India beBeeLegalExpert Full time ₹ 80,00,000 - ₹ 1,50,00,000

    Job RoleWe seek an accomplished Legal Expert to execute high-level legal functions.The ideal candidate will possess expertise in vetting responses, written submissions, and appeals under the Real Estate (Regulation and Development) Act, 2016.Vetting responses, written submissions, and appeals under the Real Estate (Regulation and Development) Act,...