
Regulatory Affairs Specialist
2 days ago
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, review, and submission processes.
This role requires coordination with internal teams and external stakeholders to ensure compliance with international guidelines and country-specific requirements. The successful candidate will be responsible for screening and analyzing documents received for product registration requests, preparing and reviewing product dossiers, and prioritizing dossiers to meet defined timelines.
The Regulatory Affairs Executive will also be responsible for drafting and coordinating responses to regulatory queries, arranging supportive batch-related documents, and managing legalization or apostillation of registration documents.
In addition, the successful candidate will support the Compliance team by providing updated documents required for technical file preparation, periodically review and update Technical Master Files, and coordinate with cross-functional teams to fulfill regulatory requirements.
Responsibilities:
- Screen and analyze documents received for product registration requests
- Prepare and review product dossiers
- Prioritize dossiers to meet defined timelines
- Draft and coordinate responses to regulatory queries
- Arrange supportive batch-related documents
- Manage legalization or apostillation of registration documents
- Support the Compliance team by providing updated documents required for technical file preparation
- Periodically review and update Technical Master Files
- Coordinate with cross-functional teams to fulfill regulatory requirements
About the Role:
This is an individual contributor role reporting to the Assistant Manager - RA, and the successful candidate will have the opportunity to work in a dynamic and collaborative environment.
-
Director of Regulatory Affairs
2 days ago
Guntur, Andhra Pradesh, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 25,00,000Director of Regulatory AffairsWe are seeking a highly skilled and experienced Director of Regulatory Affairs to lead our food regulatory initiatives. The ideal candidate will have a strong understanding of Indian food regulations, trade, and policy advocacy.Job Responsibilities:Manage the development and implementation of food regulatory policies,...
-
Global Regulatory Intelligence Specialist
1 week ago
Guntur, Andhra Pradesh, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000Global Regulatory Intelligence SpecialistAbout the RoleWe are seeking a highly skilled Global Regulatory Intelligence Specialist to join our team. As a key member of our Regulatory Intelligence team, you will play a critical role in monitoring and analyzing the global regulatory landscape within the life sciences industry.Your primary responsibility will be...
-
Regulatory Affairs Expert Lead
3 days ago
Guntur, Andhra Pradesh, India beBeeExpertise Full time ₹ 80,00,000 - ₹ 1,50,00,000Product 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 Operations Specialist
3 days ago
Guntur, Andhra Pradesh, India beBeeRegulatory Full time ₹ 1,00,00,000 - ₹ 2,00,00,000Job 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...
-
Global Regulatory Compliance Specialist
1 week ago
Guntur, Andhra Pradesh, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000Regulatory 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...
-
Medical Affairs Strategist
2 days ago
Guntur, Andhra Pradesh, India beBeeMedicalAffairs Full time ₹ 1,50,00,000 - ₹ 2,50,00,000Medical Affairs Lead RoleJob Description:The Medical Affairs Lead plays a pivotal role in driving medical strategy, focusing on providing robust support for medico-marketing initiatives and fostering collaboration between medical and marketing teams.This key position encompasses the development of medical materials, training programs, and evaluation of new...
-
IT Regulatory Specialist
3 days ago
Guntur, Andhra Pradesh, India beBeeCompliance Full time ₹ 80,00,000 - ₹ 1,20,00,000Job Title: IT Regulatory SpecialistWe are seeking a highly skilled IT Regulatory Specialist to join our team. In this role, you will be responsible for ensuring that our systems and processes comply with relevant regulatory requirements.Key Responsibilities:Develop and implement compliance strategies to ensure adherence to regulatory standards.Conduct risk...
-
Regulatory Compliance Specialist
3 days ago
Guntur, Andhra Pradesh, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 15,00,000Job Overview:We are seeking an experienced Regulatory Compliance Specialist to join our team. The successful candidate will be responsible for ensuring that our products meet all regulatory requirements and standards.Key Responsibilities:Conduct thorough research and analysis of regulatory requirements and industry standards.Develop and implement processes...
-
Regulatory Compliance Specialist
2 days ago
Guntur, Andhra Pradesh, India beBeeRegulatoryCompliance Full time ₹ 9,00,000 - ₹ 12,00,000Job Summary:We are seeking a detail-oriented professional to fill the role of Regulatory Compliance Specialist. This individual will be responsible for ensuring regulatory compliance, building relationships with government agencies, and providing operational support.Key Responsibilities:Obtain and renew necessary licenses and approvals.Establish and maintain...
-
Detail-Oriented Regulatory Expert
4 days ago
Guntur, Andhra Pradesh, India beBeeRegulatoryAffairs Full time ₹ 10,00,000 - ₹ 15,00,000Regulatory 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...