Regulatory Affairs Executive

-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...

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...

**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...

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...

**Roles and Responsibilities** - Having experience in dossier compilation (CTD & ACTD) for CIS, ASEAN, LATAM and AFRICAN countries. - Controlling the whole process of registration product from beginning till the end. - Evaluation of Bioequivalence and Clinical Trials (preferably). - **Must be B.Pharm/M.Pharm**: - Having knowledge of ICH guideline. - Having...

**JOB DESCRIPTION** **ProfileJob Title**Company Secretary and Legal Affairs**Department** **Location / Unit**Sarvodaya Hospital, Sector-8, Faridabad**Position Reports to** **Key Relationship**All doctors, All nurses, All paramedical staff, Guest Relations and all HODs.**Main Objective of the Role**Responsible for ensure that our company complies with...