Regulatory Affairs IT Architect

Hyderabad, India **Job ID** R0000012328 **Category** Regulatory / Consulting **ABOUT THIS ROLE**: **Regulatory Affairs Associate** Must have experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned...

Job Title: Regulatory Affairs ExecutiveDepartment: Regulatory AffairsLocation: HyderabadExperience: 1-5 YearsIndustry: Pharmaceuticals (Injectables / OSD)About Jodas ExpoimJodas Expoim is a fast-growing, global pharmaceutical company committed to delivering high-quality, affordable medicines. We focus on complex injectables and are driven by innovation,...

Hyderabad **Job ID**: SS202500077 **Function**: Quality **Role**: Regulatory Affairs **Desired Skills**: Regulatory, EU-MDR, Document, International Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization. Review pre-clinical, and clinical protocols and associated reports to be used in...

Job Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a...

Regulatory Affairs Manager (CMC) Career CategoryInformation Systems Job Description The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of...

GreetingsWe are seeking experienced professionals in Regulatory Affairs US Market (CMC, Module 3) with expertise in Formulation, for our Hyderabad-based R&D Centre.Regulatory Affairs US Market (CMC) with strong exposure to ANDA/NDA submissions and post-approval changes.Key Responsibilities:Hands-on experience in US Regulatory Affairs for ANDA & NDA (Approved...

Regulatory Affairs Hiring Profile eCTD SpecialistExperience Level: 3 to 6 YearsLocation: Work from office (Hyderabad)Skills & Qualifications:1.Education: Bachelor's or Masters degree in Life Sciences, Regulatory Affairs, or related field.2.Experience: 3 to 6 years of experience in regulatory affairs with a focus on eCTD submissions, preferably in the...

Job Summary:The Regulatory Affairs Manager will oversee all regulatory compliance activities related to the companys nutraceutical products, ensuring that all the marketing practices meet applicable global standards (e.g., FDA (U.S.), EFSA (EU), FSSAI (India).Key Responsibilities:Regulatory Strategy & Compliance.Develop and implement regulatory strategies...

Job Summary We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...

Role description:Amgen is seeking a Regulatory Affairs Associate Director supporting lifecycle management for approved, mature products across all Amgen Therapeutic Areas. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this...