Position Title: Assistant – Regulatory Affairs, ACG Capsules
Organization Context
Position Title:
Assistant – Regulatory Affairs, ACG Capsules
Employee Name:
Grade:
M09
Department:
Quality and Regulatory Affairs
Location:
Kandivali
Reports to:
Senior Lead - Regulatory Affairs, ACG Capsules
Reported by:
None
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 prospect 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
Functional
Core: -
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
Product – wise ARTG filing in Australia as per timelines and ensure FTR
Generate & maintain regulatory back-up data to respond to regulatory/customer queries
Preparation & maintenance of regulatory documentations for existing and new products
Provide change notifications to customers as and when required
Check and release dossier in DMS on timely basis
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📌 Assistant - Regulatory Affairs, ACG Capsules (India)
🏢 ACG
📍 India