Regulatory Affairs

**Position**: Drug Regulatory Affairs Executive **Industry**: Pharmaceutical Manufacturing (Third-Party Manufacturer) **Location**: Chandigarh, Baddi **About Us** We are a leading pharmaceutical company specializing in injectable formulations. With a strong commitment to quality and regulatory compliance, we provide innovative and high-quality solutions...

**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...

Job Title: Global Regulatory Affairs DirectorAbout the Role:This is a challenging and rewarding role that requires a strong background in regulatory affairs, operations, and intelligence. The ideal candidate will have a deep understanding of global client needs and be able to develop and implement effective project strategies to meet those needs.Key...

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,...

Role & responsibilitiesHiring for the Drug Regulatory Affair:Profile Exposure:US Export MarketDMF (Drug Master File) preparation and submissionRegulatory ComplianceHandling Regulatory QueriesPreferred candidate profile : Qualification: B.Pharma / M.Pharma / M.ScPosition: Executive / Senior ExecutiveExperience Required: Minimum 3 years (API domain)

Lead Global Regulatory SolutionsJob Description:We are seeking a seasoned Associate Vice President with 18 years of experience and an M.Pharma or Ph.D. equivalent degree in a relevant discipline to lead global clients on regulatory solutions.Key Responsibilities:Develop project strategies, scopes, and high-level timelines aligned with client...

**JOB RESPONSIBILITIES FOR DRA OFFICER** 1. Dossier writing, compilation and evaluation of dossiers as per the guidelines of various countries in CTD/ACTD and Regional format. 2. Responsible for dossier preparation/compilation & submission of assigned dossiers and maintaining data base. 3. Handling queries received by MOH/Consultant and respond the...

Required Attributes : M.Pharma / Phd equivalent degree in a relevant discipline with minimum 18 years of experience Project related responsibilities:Working with global clients on regulatory solutions including, but not limited to regulatory affairs, regulatory operations and regulatory intelligence• Understanding client requirements and planning...

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...