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 recent 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

📌 Assistant - Regulatory Affairs, ACG Capsules (India)
🏢 ACG
📍 India