
Global Regulatory Affairs Professional
14 hours ago
Job Overview:
We are seeking a skilled Regulatory Affairs Specialist to support end-to-end submissions for global markets.
Key Responsibilities- Variation Document Preparation
- Evaluate post-approval changes in compliance with global regulatory requirements.
- Compile dossier modules for Lifecycle Management activities.
- Prepare initial dossiers for global markets, considering regulations from the US, EU, SA, WHO, ANZ, and other countries.
- Develop regulatory strategies and conduct evaluations of post-approval changes considering ICH and country-specific guidelines.
- Manage submission workflows and track queries using Veeva Vault RIM.
- Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process and analytical validations, batch analysis data, and stability data.
- Minimum 3 years of experience in managing Initial submissions, Variations, and full Lifecycle management deliverables for global markets.
- Mandatory experience with Veeva Vault RIM.
- Proficient in ICH guidelines and regulatory guidelines for global markets.
- Hands-on experience in initial dossier compilation for global markets.
- Ability to provide Regulatory strategies/Evaluation by performing assessment of post approval changes considering global regulatory requirements.
- Opportunity to work on end-to-end submissions for global markets.
- Chance to develop regulatory strategies and contribute to Lifecycle Management activities.
- Cross-functional collaboration with various teams.
-
Regulatory Affairs Professional
16 hours ago
Bharatpur, Rajasthan, India beBeeCompliance Full time ₹ 36,00,000 - ₹ 40,00,000Job Overview: We seek an accomplished Regulatory Specialist to join our team and provide end-to-end support in regulatory submissions, ensuring seamless collaboration with Regulatory Commissions/Power Utilities.The ideal candidate will possess strong hands-on expertise in ARR filings, tariff determination, and petitions before SERCs/CERC.Key...
-
Corporate Regulatory Affairs Specialist
7 days ago
Bharatpur, Rajasthan, India beBeeCompliance Full time ₹ 9,00,000 - ₹ 12,00,000Job Title: Business Compliance and Regulatory Affairs SpecialistWe are seeking a dedicated professional to guide and assist businesses through the registration process, ensuring compliance with local and state regulations in India.The role demands meticulous attention to detail, comprehensive understanding of Indian corporate laws, local and state regulatory...
-
Regulatory Intelligence Specialist
5 days ago
Bharatpur, Rajasthan, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000About the OpportunityWe are seeking a skilled professional to join our team as a Regulatory Intelligence Coordinator. In this role, you will play a critical part in monitoring and analyzing the global regulatory landscape within the life sciences industry.Your primary responsibility will be to support our regulatory intelligence products and services by...
-
Quality Assurance Director
6 days ago
Bharatpur, Rajasthan, India beBeeRegulatoryAffairs Full time ₹ 80,00,000 - ₹ 1,50,00,000At the forefront of quality assurance, we seek a visionary leader to spearhead our regulatory affairs initiatives.The ideal candidate should possess 5-7 years of experience and hold a degree in pharmaceutical sciences, with relevant expertise in medical device regulation.Key Responsibilities:Ensure compliance with ISO standards, EU directives, and GMP...
-
Senior Regulatory Affairs Professional
1 week ago
Bharatpur, Rajasthan, India beBeeCompliance Full time ₹ 30,00,000 - ₹ 50,00,000Regulatory Compliance ManagerThis role involves overseeing the effective communication between departments and maintaining a thorough understanding of local authorities and government regulations.Main Responsibilities:Evaluate and implement compliance strategies to ensure adherence to local, state, and federal regulations and industry standards.Monitor...
-
Senior Food Regulatory Specialist
5 days ago
Bharatpur, Rajasthan, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000Job Opportunity:Senior Food Regulatory SpecialistThis role involves leading regulatory intelligence on domestic and international food labelling regulations across various markets.Responsibilities include monitoring, analysing and interpreting global regulatory updates and translating them into actionable implications for food businesses.A thorough...
-
Regulatory Affairs Specialist
5 days ago
Bharatpur, Rajasthan, India beBeeCompliance Full time ₹ 60,00,000 - ₹ 1,20,00,000Compliance Expert Wanted The Compliance Officer will be responsible for ensuring the organization's compliance with all applicable statutory, regulatory, and internal governance requirements. Key Responsibilities: Conduct comprehensive reviews and maintain documentation to ensure adherence to regulatory requirements and internal standards.Evaluate the...
-
BLA Regulatory Publishing Professional
3 days ago
Bharatpur, Rajasthan, India beBeeeCTD Full time ₹ 9,00,000 - ₹ 12,00,000Regulatory Publishing Specialist – eCTD ExpertWe are seeking a skilled Regulatory Publishing Specialist to lead our BLA submissions in eCTD format using Veeva Vault eCTD Publishing. The ideal candidate will have extensive experience in global regulatory requirements and compliance.Key Responsibilities:Prepare and manage BLA submissions in eCTD format using...
-
Compliance Specialist
7 days ago
Bharatpur, Rajasthan, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 15,00,000Job Title: Regulatory Compliance ManagerOverview:We seek a seasoned professional with expertise in regulatory affairs for pharmaceuticals and medical devices.The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations.Key Responsibilities:Prepared regulatory...
-
Regulatory Compliance Specialist
3 days ago
Bharatpur, Rajasthan, India beBeeCompliance Full time ₹ 90,00,000 - ₹ 1,20,00,000Job Overview\We are seeking a Regulatory Compliance Specialist to support end-to-end submissions for global markets. As a key member of our team, you will play a crucial role in ensuring compliance with global regulatory requirements.\