Assistant - Regulatory Affairs, ACG Capsules

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 .

1. 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

1. 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.

1. 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

1. Key Interfaces

Internal Interfaces

External Interfaces

• CSR
• Sales (TIC)
• Plant Quality & Operational

• Customer
• Certification Agency
• Regulatory Agency