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Assistant - Regulatory Affairs, ACG Capsules
Healthcare Medical
💰 Salary Not shared
📊 Market ₹25,000–₹45,000/mo (₹300,000–₹540,000/yr)
About the Company
ACG is the world's largest provider of integrated manufacturing solutions for pharmaceutical and nutraceutical companies focused on oral solid dosage medicines. For sixty-five years, we have served as a global partner to manufacturers across more than 130 countries, uniquely unifying every critical element of the oral solid dosage manufacturing ecosystem. Our expertise supports the full spectrum of end-to-end encapsulation and tabletting. Our comprehensive portfolio spans from gelatin and HPMC empty capsules, encapsulation machines, and blister packaging materials, to granulation, tablet compression, and coating machines, through to blister packaging, cartoning, inspection machines, and track & trace systems. Innovation and advanced manufacturing are central to how we operate. Our packaging materials facility in Shirwal, India was recently inducted into the World Economic Forum's Global Lighthouse Network, following the earlier recognition of our Pithampur capsules manufacturing facility in 2023. We believe that our integrated view of manufacturing is the best approach to uniting seamless production with fully accountable service, and ultimately 'making it better'. Pharmaceutical Manufacturing Specialties: HPMC capsules, gelatin capsules, blister packaging materials, fluid bed granulators, high-shear mixers, capsule-filling machines, tablet compression machines, tablet coating machines, blistering machines, cartoning machines, inspection technologies, track & trace systems
Responsibilities
- ● Position Title: Assistant - Regulatory Affairs, ACG Capsules
- ● Organization Context
- ● Position Title
- ● Assistant - Regulatory Affairs, ACG Capsules
- ● Employee Name
- ● Quality and Regulatory Affairs
- ● Senior Lead - Regulatory Affairs, ACG Capsules
- ● ACG is the world's only integrated pharma manufacturing solutions company. We are headquartered in Mumbai, India. ACG has a presence in over 100 countries with its products and services that strive to provide world-class technology across multiple domains. We offer a complete range of solutions beginning with empty capsules; granulation and tablet coating; capsule filling; tabletting; packaging films; blister packing and carton packing to the end-of-line solutions and track and trace systems.
- ● We have an opportunity in ACG Capsules of an Assistant - Regulatory Affairs, Quality and Regulatory Affairs, Central .
- ● Job Objective
- ● Provide regulatory support to customers in order to meet current and new regulatory norms
- ● Life cycle management of existing dossier in various countries to meet customer and regulatory norms
- ● Primary responsibilities
- ● Strategic and planning
- ● Ensure compliance to all regulatory norms (new & existing)
- ● Prepare & submit Drug Master files in CTD format for the respective regions on annual & biannual basis along with issuance of LOA
- ● Handling customer questionnaires / specification on timely manner
- ● Respond to customer / regulatory queries within pre-defined timelines
- ● Conduct regulatory checks of shades & artwork
- ● Obtain / renew regulatory certificates on timely manner
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