Global Regulatory Affairs Coordinator
7 days ago
A career opportunity exists for an experienced International Regulatory Affairs Executive to join our client's regulatory affairs team in the medical device manufacturing industry.
Company OverviewOur client is a leading manufacturer and exporter of urology, laparoscopy, gynecology, dialysis, cardiology, and gastrology products. They have established their presence in over 85 countries worldwide.
Job SummaryThe International Regulatory Affairs Executive will play a crucial role in ensuring compliance with international regulatory guidelines, coordinating with internal teams, and liaising with regulatory authorities for approvals. Key responsibilities include dossier preparation and submission, regulatory compliance and documentation, coordination and communication, and regulatory intelligence and updates.
Responsibilities- Dossier Preparation & Submission:
- Compile, review, and submit regulatory dossiers as per country-specific requirements for ROW, Asian, and African markets.
- Ensure timely preparation and submission of dossiers, including CTD, ACTD, and country-specific formats.
- Maintain up-to-date knowledge of international regulatory guidelines (ICH, WHO, country-specific regulations).
- Ensure compliance with regulatory requirements for product registration, renewals, and variations.
- Prepare and review technical documents, including stability data, product formulation, and analytical reports.
- Liaise with internal departments such as R&D, Quality Assurance, Quality Control, and Production to collect required documents.
- Communicate with regulatory authorities and clients to address queries and ensure smooth approval processes.
- Monitor and update changes in regulatory guidelines for ROW, Asian, and African markets.
- Implement necessary updates in documentation and processes to align with regulatory changes.
- 1 or 2 years of experience in Regulatory Affairs for ROW, Asian, and African markets.
- Prior experience in dossier preparation and submissions.
- Strong understanding of regulatory guidelines and dossier requirements.
- Detail-oriented with strong documentation and organizational abilities.
- Proficiency in MS Office (Word, Excel, PowerPoint).
Contact Person: Neha Sharma
-
Regulatory Affairs Specialist
1 day ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeCompany OverviewOur client is a leading medical device manufacturer with a global presence, producing urology, laparoscopy, gynecology, dialysis, cardiology, and gastrology products.Their brand is recognized in over 85 countries worldwide.Job DescriptionThe International Regulatory Affairs Executive will be responsible for preparing and submitting regulatory...
-
Regulatory Affairs Specialist
2 days ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeOur client, a leading medical device manufacturer, is seeking an experienced Regulatory Affairs Specialist to join their team.Job Overview:The successful candidate will be responsible for ensuring compliance with international regulatory guidelines and coordinating with internal teams to facilitate product approvals.This role requires strong communication...
-
Global Regulatory Coordinator
6 days ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeRole Overview:This is an exciting opportunity to join our regulatory affairs team as a key member responsible for ensuring the successful preparation and submission of regulatory dossiers for our pharmaceutical products in various international markets.Main Duties:1. Regulatory Dossier Preparation* Prepare and submit regulatory dossiers, including CTD, ACTD,...
-
Global Regulatory Associate
1 day ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeRegulatory Affairs PositionWe are a leading medical device manufacturing company seeking an experienced Regulatory Affairs professional to join our team as an International Regulatory Affairs Executive.Job Responsibilities:The successful candidate will be responsible for preparing and submitting regulatory dossiers for pharmaceutical products in Rest of the...
-
Regulatory Affairs Associate
6 days ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeInternational Regulatory Affairs Executive The International Regulatory Affairs Executive will be responsible for preparing and submitting regulatory dossiers for pharmaceutical products in Rest of the World (ROW), Asian, and African markets. Key Responsibilities: Dossier Preparation & Submission: Ensure timely preparation and submission of dossiers,...
-
Global Regulatory Affairs Expert
4 days ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeRequirements & QualificationsPreferred Experience: 1 or 2 years of experience in Regulatory Affairs for ROW, Asian, and African markets.Prior Experience: Prior experience in dossier preparation and submissions.Skills & Qualifications: Strong understanding of regulatory guidelines and dossier requirements, detail-oriented with strong documentation and...
-
Regulatory Affairs Associate
4 days ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeCompany Details :Our client is an India's Largest and Leading Manufacturer and Exporter of Urology, Laparoscopy, Gynecology, Dialysis, Cardiology, and gastrology products.Their Brand Presents in More Than 85 Countries.Designation : - International RA ExecutiveJob Profile : -The International Regulatory Affairs Executive will be responsible for preparing...
-
Regulatory affairs associate
3 days ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeCompany Details : Our client is an India's Largest and Leading Manufacturer and Exporter of Urology, Laparoscopy, Gynecology, Dialysis, Cardiology, and gastrology products. Their Brand Presents in More Than 85 Countries.Designation : - International RA ExecutiveJob Profile : -The International Regulatory Affairs Executive will be responsible...
-
International Regulatory Coordinator
1 day ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeJob Title: International Regulatory Affairs ExecutiveCompany Overview:We are a leading medical device manufacturing company with a global presence. Our products cater to various healthcare needs, including urology, laparoscopy, gynecology, dialysis, cardiology, and gastrology.Job Summary:The successful candidate will be responsible for preparing and...
-
Regulatory Affairs Associate
7 days ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeCompany Details : Our client is an India's Largest and Leading Manufacturer and Exporter of Urology, Laparoscopy, Gynecology, Dialysis, Cardiology, and gastrology products. Their Brand Presents in More Than 85 Countries. Designation : - International RA Executive Job Profile : - The International Regulatory Affairs Executive will be responsible for...
-
Regulatory Affairs Associate
1 week ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeCompany Details: Our client is an India's Largest and Leading Manufacturer and Exporter of Urology, Laparoscopy, Gynecology, Dialysis, Cardiology, and gastrology products. Their Brand Presents in More Than 85 Countries.Designation: - International RA Executive Job Profile: -The International Regulatory Affairs Executive will be responsible for preparing and...
-
Regulatory Affairs Specialist
6 days ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeJob Summary:The International Regulatory Affairs Executive will be responsible for preparing and submitting regulatory dossiers for pharmaceutical products in Rest of the World (ROW), Asian, and African markets.Main Responsibilities:1. Dossier Preparation & Submission* Ensure timely preparation and submission of dossiers, including CTD, ACTD, and...
-
Regulatory Affairs Senior Manager
6 days ago
Ahmedabad, Gujarat, India Biomatrix healthcare Full timeBioMatrix Healthcare, a leading healthcare company headquartered in Ahmedabad, India, is seeking an experienced Regulatory Affairs Senior Manager to join its team. As a key member of the regulatory affairs team, you will be responsible for ensuring compliance with drug regulations, leading the team, and supporting our expansion into new markets.The ideal...
-
Regulatory Affairs Specialist
4 days ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeJob OverviewWe are seeking a highly skilled Regulatory Affairs Associate to join our team at Medical Device Manufacturing. The successful candidate will be responsible for preparing and submitting regulatory dossiers for pharmaceutical products in Rest of the World (ROW), Asian, and African markets.
-
Global RA Coordinator
2 days ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeWe are looking for a skilled Global RA Coordinator to join our team in supporting the preparation and submission of regulatory dossiers for pharmaceutical products in Rest of the World (ROW), Asian, and African markets.Responsibilities:Monitor and update changes in regulatory guidelines for ROW, Asian, and African markets.Implement necessary updates in...
-
Medical Device Regulatory Coordinator
4 days ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeAbout the RoleThe International Regulatory Affairs Executive will play a critical role in ensuring compliance with international regulatory guidelines, coordinating with internal teams, and liaising with regulatory authorities for approvals. Key responsibilities include dossier preparation & submission, regulatory compliance & documentation, coordination &...
-
Senior Regulatory Affairs Officer
2 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeJob Title: Senior Regulatory Affairs Officer Job Location: Ahmedabad, Gujarat, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Associate Skills:Regulatory Affairs, Quality Assurance, Regulatory Strategy Development, Class III Medical Devices, Product Registration, international legislation, accreditation requirements,...
-
Senior Regulatory Affairs Officer
4 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeJob Title: Senior Regulatory Affairs Officer Job Location: Ahmedabad, Gujarat, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Associate Skills:Regulatory Affairs, Quality Assurance, Regulatory Strategy Development, Class III Medical Devices, Product Registration, international legislation, accreditation requirements,...
-
Senior Regulatory Affairs Executive
3 weeks ago
Ahmedabad, Gujarat, India Synerxia Healthcare Full timeJob description SYNERXIA Healthcare Pvt Ltd is engaged into Manufacturing & Exports of Nutraceuticals-Health/Dietary Supplements along with Pharmaceutical Products, is one of the Upstart organization is looking forposition in Regulatory Affairs - Emerging / ROW Market for pre-submission and post-submission . Role and responsibilities 1.Responsible for...
-
Senior Regulatory Affairs Executive
4 weeks ago
Ahmedabad, Gujarat, India Synerxia Healthcare Full timeJob descriptionSYNERXIA Healthcare Pvt Ltd is engaged into Manufacturing & Exports of Nutraceuticals-Health/Dietary Supplements along with Pharmaceutical Products, is one of the Upstart organization is looking for position in Regulatory Affairs - Emerging / ROW Market for pre-submission and post-submission.Role and responsibilities1. Responsible...