Am - Drug & Regulatory Affairs (Pharmaceutical

**Roles and Responsibilities** - Provide comprehensive regulatory support throughout the product lifecycle, including vendor selection, API development, scale-up, validation, dossier filing, query handling, and post-approval life cycle management. - Support the Analytical Research Development and Chemical Research Division in the development of new APIs and...

Roles and Responsibilities Provide comprehensive regulatory support throughout the product lifecycle, including vendor selection, API development, scaleup, validation, dossier filing, query handling, and postapproval life cycle management. Support the Analytical Research Development and Chemical Research Division in the development of new APIs and proposed...

Position: Regulatory Senior Consultant/ Consultant - CMC Location: Hybrid (80 % remote, 20 % In office) Reports To: Manager or above, Regulatory Affairs unctional Responsibilities - Work with global clients on regulatory filing projects for USFDA, EMA, MHRA, APAC, Canada etc. The key delivery areas include Pre and Post approval CMC authoring, preparation,...

When our values align, there's no limit to what we can achieve.   Regulatory Affairs Labeling Must have 4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. Good working knowledge of key labeling regulations/guidance and past...

When our values align, there's no limit to what we can achieve.   8+ years’ experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market. Good understanding of regulatory framework, including regional trends, for various types of...

When our values align, there's no limit to what we can achieve.   8+ years’ experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market. Good understanding of regulatory framework, including regional trends, for various types of...

Chitkara University is looking for Assistant & Associate Professor in Chitkara School of Pharmacy at Chitkara University Himachal Pradesh.Chitkara College of Pharmacy has been ranked 16th for Pharmacy by NIRF 2023. The College offers full-time courses in the areas of Pharmacy, which include B. Pharm, Pharm.D., Phar.D. (Post Baccalaureate), M Pharmacy and...

Chitkara University is looking for Assistant & Associate Professor in Chitkara School of Pharmacy at Chitkara University Himachal Pradesh. Chitkara College of Pharmacy has been ranked 16th for Pharmacy by NIRF 2023. The College offers full-time courses in the areas of Pharmacy, which include B. Pharm, Pharm.D., Phar.D. (Post Baccalaureate), M Pharmacy and...

**A leading contract research organization trusted by leaders**: Position Code: DSP001 **Location**: Chandigarh Report preparation [e.g. Periodic Benefit Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, US Periodic Adverse Drug Experience Reports (PADERs)]...

Position Code: DSP001 **Location**: Chandigarh Report preparation [e.g. Periodic Benefit Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, US Periodic Adverse Drug Experience Reports (PADERs)] from aggregate data for products, in accordance with client...

When our values align, there's no limit to what we can achieve.Job Purpose:Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed productsSignal detection/analysis/evaluation and ongoing safety surveillance activitiesProvide medical...

Job Purpose:Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed productsSignal detection/analysis/evaluation and ongoing safety surveillance activitiesProvide medical guidance and input to Drug Safety associates (DSAs) and...

Job Purpose:Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed productsSignal detection/analysis/evaluation and ongoing safety surveillance activitiesProvide medical guidance and input to Drug Safety associates (DSAs) and...

Drug Safety Physician role. Attached is the JD for your reference. Experience required: 0 - 2 years Qualification requirements: MBBS or MD Vacancies: 5 Work Location: Chandigarh Office Job responsibilities: - Providing medical advice to PV Scientists to assist them with processing of ICSRs - Review of published literature articles/abstracts -...

When our values align, there's no limit to what we can achieve.   Job Purpose: Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products Signal detection/analysis/evaluation and ongoing safety surveillance activities ...

Job Title: Company Secretary - Legal (Pharmaceutical Industry) **Company Overview**: **Reputed company collaborated with Ind-Swift** **Job Summary**: **Responsibilities**: **Corporate Governance**: - Oversee compliance with corporate governance regulations and guidelines. - Maintain accurate records of board meetings, resolutions, and governance...

When our values align, there's no limit to what we can achieve. The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). Assignment Category -...

When our values align, there's no limit to what we can achieve.   The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). Assignment Category -...

Indivirtus Healthcare, a fastest growing CRO, is the parent company of Indivirtus Group. **In just 4.5 years Indivirtus healthcare has served 310+ clients in 35+ countries across 6 continents and has established 5 international business offices** Having started in 2018, today Indivirtus is a group of 4 companies Indivirtus Healthcare offers following...

Indivirtus Healthcare, a fastest growing CRO, is the parent company of Indivirtus Group. **In just 4.5 years Indivirtus healthcare has served 310+ clients in 35+ countries across 6 continents and has established 5 international business offices** Having started in 2018, today Indivirtus is a group of 4 companies Indivirtus Healthcare offers following...