ACG World
Website:
acg-world.com
Job details:
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 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
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
- Provide regulatory support to Plant QA and International RA teams as and when required
- Verify regulatory acceptance of various ingredients in various countries for existing and new products
- Maintenance and updation of data in internal online systems
Internal Process
- Publication of regulatory updates in order to create awareness among internal stakeholders
People development
- Train CSR team and Plant associates (if required) on regulatory requirements
- Any other additional responsibility could be assigned to the role holder from time to time as a standalone project or regular work. The same would be suitably represented in the Primary responsibilities and agreed between the incumbent, reporting officer and HR.
- Key Result Areas
- Timely resolution of customer / regulatory queries (FTR)
- Timely submission of regulatory filing for existing products
- Renewal of regulatory certificates for existing & new products on timely manner
- Key Interfaces
Internal Interfaces
External Interfaces
- CSR
- Sales (TIC)
- Plant Quality & Operational
- Customer
- Certification Agency
- Regulatory Agency
Click on Apply to know more.
