
Submission Reviewer
2 hours ago
Major duties and responsibilities:
Submission Reviewer is a centralized role that:
- Has oversight of the reporting rules configuration for compounds, marketed drugs,
devices, and vaccines to ensure proper distribution / submission to health authorities,
affiliate countries, license partners / collaboration partners.
- Has regulatory reporting expertise in all major regions.
- Performs regulatory reporting in all major regions in accordance with policies, SOPs
and HA regulations. Has oversight of ICSR submission related activities in all regions,
ensuring safety database is operational, prompt escalation of system outage affecting
ICSR distribution / submission process.
- Distribution of “Dear investigator letter” to investigators.
- Is the SME during internal / partner audits and inspections.
- Provide or receive training on Customer-specific processes, systems, or products.
- Other tasks as required.
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Safety & Pv Submission Spec Ii
2 days ago
Remote, India Syneos - Clinical and Corporate - Prod Full time**Description** **Senior Safety & Pharmacovigilance Submissions Specialist** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model...
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Us Business Tax Reviewer
2 hours ago
Remote, India CRSP Connect Pvt.Ltd Full time**Job Title: US Tax Reviewer** **Location**: Udaipur / Remote **Shift Timings**: 3:00 PM - 12:00 AM IST or 5:00 PM - 2:00 AM IST **About the Company** **CRSP Connect LLC, NY, USA**, a subsidiary of **CRSP Connect Private Limited, India**, provides high-quality Knowledge Process Outsourcing (KPO) services to CPA firms and businesses across the United...
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US Business Tax Reviewer
7 days ago
Remote, India CRSP Connect Pvt Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Title: US Tax ReviewerLocation: Udaipur / RemoteShift Timings: 3:00 PM – 12:00 AM IST or 5:00 PM – 2:00 AM ISTAbout the CompanyCRSP Connect LLC, NY, USA, a subsidiary of CRSP Connect Private Limited, India, provides high-quality Knowledge Process Outsourcing (KPO) services to CPA firms and businesses across the United States. Our specialized tax...
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Regulatory Affairs Officer
1 week ago
Remote, India ProductLife Group Full time**Responsibilities**: - Contribute to regulatory activities performed on the RA Platform/the Hub. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions. - To contribute to the production of client administrative documents to be included in regulatory submissions -...
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Regulatory Affairs Officer
2 weeks ago
Remote, India ProductLife Group Full timeResponsibilities - Contribute to regulatory activities performed on the RA Platform/the Hub. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions. - To contribute to the production of client administrative documents to be included in regulatory submissions - Compile...
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Cta Officer
7 days ago
Remote, India ProductLife Group Full time**Responsibility**: **Operational Activity**: Preparation and submission of CTA in EU and outside of EU from initial CTA preparation until notification of results Review of documents (clinical study protocol, Informed consent form,) Capacity to provide the technical/practical regulatory expertise on the documents and on submission strategy Coordinator...
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Statistical Programmer
2 weeks ago
Remote, India TruMinds Technology Inc Full time ₹ 12,00,000 - ₹ 25,00,000 per yearAbout the RoleLocation : Remote (India)We are seeking a highly skilled Senior Statistical Programmer to join our growing Biometrics team. The ideal candidate will be responsible for providing advanced programming support for the analysis and reporting of clinical trial data in compliance with regulatory requirements. This role will involve working closely...
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Regulatory Affairs Associate
3 days ago
Remote, India Parexel Full timeAs part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...
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Visa Executive
2 weeks ago
Remote, India TRINITY INTERNATIONAL TOURS AND TRAVELS Full time(Trivandrum,Kollam,Ernakulam,Kozhikode,Chennai,Bengaluru) **Key Responsibilities**: - Maintain up-to-date knowledge of visa rules, regulations, and requirements of different countries. - Communicate with embassies, consulates, and clients to resolve queries and ensure smooth processing. - Review documents for accuracy and compliance before submission. -...
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Study Start Up Associate Ii
2 hours ago
Remote, India ICON Full time**At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.** **Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...