
Regulatory Publishing Specialist
2 weeks ago
We are seeking a highly skilled Regulatory Publishing Specialist to join our team. This individual will be responsible for preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing.
">Key Responsibilities:
- Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing, ensuring compliance with regulatory guidelines and internal processes.
- Compile, format, and publish regulatory documents according to global health authority requirements, maintaining attention to detail and organizational skills.
- 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, tracking submission timelines and deliverables to meet regulatory deadlines.
Required Skills & Qualifications:
- Strong experience in Veeva Vault eCTD Publishing for BLA submissions, with knowledge of global regulatory requirements.
- Hands-on experience in preparing eCTD sequences and publishing ready dossiers, with good communication skills to collaborate with multiple stakeholders.
- Attention to detail, strong organizational skills, and prior experience in Life Sciences / Pharma regulatory publishing are mandatory.
Why this Role is Important:
This role is critical to the success of our regulatory publishing efforts, requiring a skilled professional who can balance complexity and deadlines while maintaining high-quality output.
-
Regulatory Compliance Specialist
2 weeks ago
Kollam, Kerala, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000Job Title: Regulatory Compliance SpecialistKey ResponsibilitiesThe successful candidate will have a strong background in auditing, with a focus on regulatory compliance and enforcement.We are seeking a highly motivated individual to analyze system audit reports, review MIS for delays and non-compliance, and address ATR and follow-on issues.Required Skills...
-
Regulatory Compliance Expert
2 weeks ago
Kollam, Kerala, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 20,00,000Regulatory Specialist Job DescriptionJob SummaryAs a Regulatory Specialist, you will be responsible for handling regulatory filings and ensuring compliance with frameworks in the power sector.Key ResponsibilitiesHandling ARR filings, tariff determination, petitions, and regulatory analysisDrafting and submitting regulatory petitions, compliance reports,...
-
Financial Services Regulatory Professional
2 weeks ago
Kollam, Kerala, India beBeeRegulatorySpecialist Full time ₹ 1,50,00,000 - ₹ 2,50,00,000Regulatory SpecialistWe are seeking an experienced professional to oversee regulatory activities and related developments across regions. This is an exciting opportunity to work within a dynamic team that manages supervisory activities of regulators and related developments.This role involves managing and coordinating regulatory examinations, overseeing...
-
Regulatory Compliance Specialist
2 weeks ago
Kollam, Kerala, India beBeeCompliance Full time ₹ 1,20,00,000 - ₹ 2,00,00,000**Compliance Professional - Regulatory Specialist**At our organization, our culture is built on a strong foundation of innovation, shared values, and leadership behaviors. As part of our team, you'll experience comprehensive support for your holistic well-being and many opportunities to learn new skills, develop as a leader, and grow your...
-
Regulatory Assurance Expert
2 weeks ago
Kollam, Kerala, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 24,00,000Job Title: Compliance Assurance SpecialistAbout This RoleWe are seeking a highly skilled Compliance Assurance Specialist to join our team.Key Responsibilities:Compliance and ValidationHands-on experience in compliance and validation roles, with strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.System validation aligned with regulatory standards,...
-
Regulatory Compliance Specialist
1 week ago
Kollam, Kerala, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 12,00,000Job Title: Regulatory Compliance Liaison">Job Description:We are seeking a detail-oriented and organized Regulatory Compliance Liaison to join our team. The successful candidate will be responsible for ensuring all necessary licenses and approvals are obtained and renewed in a timely manner.Key Responsibilities:Obtain and renew mandatory licenses and...
-
Senior Compliance Officer
2 weeks ago
Kollam, Kerala, India beBeeAnalytical Full time ₹ 2,00,00,000 - ₹ 2,50,00,000Regulatory reporting specialists play a pivotal role in ensuring organizations meet regulatory requirements. We seek an experienced Regulatory Reporting Manager to join our team.The successful candidate will have 7+ years of experience in regulatory reporting, with a strong understanding of APRA / Basel 3 Credit risk calculation, reporting processes and...
-
Global Regulatory Affairs Specialist
1 week ago
Kollam, Kerala, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 15,00,000Job Description:The key objective of this Regulatory Affairs Professional is to prepare, review and maintain regulatory documents ensuring compliance with international guidelines and country-specific requirements.This role coordinates with internal teams and external stakeholders to support product registrations timely dossier submissions query responses...
-
Senior Regulatory Specialist
2 weeks ago
Kollam, Kerala, India beBeeStrategic Full time ₹ 15,00,000 - ₹ 17,50,000Product Registration Strategic LeaderAs a key member of our Product Stewardship organization, you will play a pivotal role in ensuring the marketability of our products in regulated countries.In this strategic position, you will develop and implement registration projects based on a global registration strategy.Key responsibilities include:Developing and...
-
Regulatory Liaison Specialist
1 week ago
Kollam, Kerala, India beBeeGovernment Full time ₹ 15,00,000 - ₹ 25,00,000Job Overview:We are seeking an experienced professional to lead Approvals & Coordination activities with various government departments.About the RoleThe ideal candidate should have a strong track record of obtaining necessary approvals and clearances while effectively liaising with multiple authorities.Key ResponsibilitiesManage and coordinate approvals...