Current jobs related to Global Regulatory Affairs Specialist - Chennai, Tamil Nadu - beBeeRegulatory
-
Regulatory Affairs Specialist
2 weeks ago
Chennai, Tamil Nadu, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 20,00,000Regulatory Affairs Role in Pharma Industry">Candidates should review and prepare regulatory submissions, including new filings and amendments to Annual reports. This includes reviewing of DMF for USFDA registration activities. ">Key Responsibilities">1. Review and preparation of regulatory submissions2. Management of DMF and USFDA registration activities...
-
Regulatory Affairs Opportunities
2 weeks ago
Chennai, Tamil Nadu, India beBeeRegulatoryAffairs Full time ₹ 9,00,000 - ₹ 15,00,000Regulatory Affairs Opportunities">Candidates seeking a challenging role in regulatory affairs will find this position appealing.The ideal candidate will be responsible for preparing and submitting regulatory documents, including new drug applications (NDAs) and annual reports. Additionally, they will manage US FDA registration activities and oversee the...
-
Chief Regulatory Affairs Specialist
2 weeks ago
Chennai, Tamil Nadu, India beBeeRegulatory Full time ₹ 9,60,000 - ₹ 12,00,000Regulatory Affairs PositionManage regulatory submissions, including new drug applications (NDAs), complete response letters (CRLs), information requests (IRs), and amendments to existing NDAs.File post-approval and prior approval supplements in compliance with FDA regulations.Review change controls to assess their impact on regulatory alignment and ensure...
-
Regulatory Compliance Specialist
2 weeks ago
Chennai, Tamil Nadu, India beBeeCompliance Full time ₹ 90,00,000 - ₹ 1,20,00,000Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team. The key objective of this role is to prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements.The role involves coordination with internal teams and...
-
Chennai, Tamil Nadu, India beBeeFoodRegulator Full time ₹ 19,05,000 - ₹ 24,30,000Job Title:Senior Assistant Director">Job Description:Our organization seeks a highly skilled and motivated professional to lead and manage activities in the Food Regulatory Affairs department.">Key Responsibilities:Drive policy initiatives to support the food industry.Engage with government departments, industry stakeholders, and generate...
-
Regulatory Partnership Specialist
1 week ago
Chennai, Tamil Nadu, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,20,00,000Job Title: Regulatory Partnership SpecialistWe are seeking a skilled professional to serve as our primary point of contact with regulatory bodies and industry associations.Main Responsibilities:Serve as liaison with regulatory bodies, insurance companies, and government agencies.Oversee statutory compliances, audits, and regulatory filings to ensure seamless...
-
Chennai, Tamil Nadu, India Seven Consultancy Full timeJOB DETAILS Candidates should review and prepare regulatory submissions, including new ANDA filings, amendments and Annual reports to the ANDA.Review of DMF Manages USFDA registration activities FUNCTIONAL AREA Pharma Jobs Consultancy in Chennai, Pharma Jobs Consultancy near me, Pharma Jobs, Top, Best, Jobs Consultancy in Chennai, regulatory affairs jobs...
-
Corporate Regulatory Compliance Expert
2 weeks ago
Chennai, Tamil Nadu, India beBeeRegulatoryLiaison Full time ₹ 10,00,000 - ₹ 15,00,000Regulatory Liaison SpecialistWe are seeking an experienced professional in regulatory affairs to join our team.As a liaison officer, you will act as the primary interface between our organization and external stakeholders including regulatory bodies, insurance companies, government agencies, and industry associations.Your role will be critical in ensuring...
-
Chennai, Tamil Nadu, India Seven Consultancy Full timeJOB DETAILS Manages, reviews, and authors regulatory submissions, including new ANDA filings, complete response letters (CRLs), information requests (IRs), and amendments to existing ANDAs.Responsible for filing Post-Approval and Prior Approval Supplements in compliance with FDA requirements.Reviews change controls to assess regulatory impact and ensure...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Chennai, Tamil Nadu, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 28,00,000Key Responsibilities:Prepare, review and submit amendments and supplements for the assigned products.Compile summary documents for regulatory submission.Respond to agency queries in a timely manner.Submit Global Annual Reports on time.Review stability protocols and reports for analytical method validation.Examine raw material, packaging material and finished...
Global Regulatory Affairs Specialist
2 weeks ago
Key Responsibilities:
- Prepare regulatory submissions and evaluate post-approval changes in compliance with global regulations.
- Contribute to Lifecycle Management activities by compiling and reviewing technical dossier modules.
- Compile initial dossiers for various countries, including US, EU, SA, WHO, ANZ, and others.
- Provide regulatory strategies and conduct evaluations of post-approval changes considering ICH and country-specific guidelines.
- Manage submission of variations/supplements for multiple countries.
Experience Requirements:
- Minimum 3 years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets.
- Proven experience with RIM systems.
- Familiarity with ICH guidelines and regulatory requirements for various countries.
- Hands-on experience in dossier compilation and technical document review.
- Ability to provide regulatory strategies and evaluate post-approval changes.
