Assistant - Regulatory Affairs ACG Capsules

ACG World; Mumbai; On-site; INR 350,000 - 650,000; Full time

Job summary

ACG Capsules, based in Mumbai, seeks an Assistant – Regulatory Affairs to support regulatory submissions and lifecycle management across regions. You will ensure compliance with current norms and prepare DMF/CTD filings, coordinating with global teams.

You will also respond to regulatory queries, maintain documentation, and assist in updates, certificates, and artwork checks, contributing to timely regulatory deliverables for multiple products.

Qualifications

• Provide regulatory support to customers to meet regulatory norms.
• Lifecycle management of dossiers across multiple regions.

Responsibilities

• Prepare and submit DMFs/CTD filings for respective regions.
• Respond to customer/regulatory queries within defined timelines.
• Maintain and update regulatory documentation for products.

Skills

Regulatory knowledge

Documentation

Dossier preparation

Job description

Job Description

Position Title: Assistant – Regulatory Affairs, ACG Capsules

• 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

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

External Interfaces

• CSR
• Sales (TIC)
• Plant Quality & Operational
• Customer
• Certification Agency
• Regulatory Agency