Executive- Drug Regulatory Affairs

**Responsibilities**: - **Regulatory Compliance**: - Stay abreast of current and evolving regulations related to Drug License and FSSAI requirements. - Ensure the organization's adherence to all applicable government regulations and standards. - **Drug License Application**: - Coordinate with regulatory authorities for timely approvals and compliance...

We are hiring Regulatory Affairs Executive for a Medical Device Equipment company. Key skills: Thorough Knowledge of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017 - 2+ years of experience implementing test strategies, test plans and test cases for validation and verification in FDA-compliant medical...

-Full Time Gurgaon Posted 5 days ago Job title Associate - Regulatory Affairs - Reports to Senior Associate/Astt Manager/Manager - Regulatory Affairs - **Job purpose**: To carry out Regulatory Review and Compilation of Technical documentation & dossiers for - Various Markets in compliance to applicable regulations and guidelines. - **Duties and...

Posted 3 hours ago Job purpose To perform medical review and oversight of processing for all types of safety events, and other medically-related project information. Provide medical oversight and completion of analysis of similar events, company causality assessment, and expectedness assessment, review of MedDRA coding, causality assessment signal detection,...

Job Description : We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. The ideal candidate will have a proven track record of authoring, managing, and receiving clearances for FDA 510(k) submissions. Must have a deep knowledge of regulatory requirements and processes for medical devices. This role will...

Job Description: - Submit labels and leaflets based on the official gazette notification and renew documents as per the established plan. - Prepare and submit the dossier, and follow up on registration processes for various geographies. - Manage legalization, notarization, and channelization for regulatory support. - Systematically follow up for data...

DDReg Pharma DDReg Pharma Full Time Gurgaon Posted 5 hours ago **Job Purpose**: **Key Responsibilities**: **Compliance & Lifecycle Management**: Prepare variation and requalification dossiers. Manage regulatory product maintenance across EU, UK, WHO, and other emerging markets. **eCTD/CTD Sequence Review**: Perform Level-1 review of CTD/eCTD sequences for...

Quality Systems Management: Develop, implement, and maintain quality systems and processes to ensure compliance with regulatory requirements, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP). - Document Control: Manage document control processes, including document creation, review,...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

Our client is in search of a Government Affairs Manager for a MedTech company onsite in Gurgaon, India.The RoleThe Government Affairs Manager will be responsible for public policy engagement, government KOL advocacy, and initiating project-based collaborations with central and state health authorities to influence healthcare policy development. The role will...