Sandoz is hiring for three Regulatory Affairs positions in Telangana. The openings support regulatory operations, submission information management, artwork activities, regulatory databases, compliance, documentation, and lifecycle management for the Australia and New Zealand (ANZ) market.

All three positions are full-time and require candidates with pharmaceutical industry experience. The application deadline for the listed roles is October 16, 2026.

Job Details

Positions Available

1. Regulatory Affairs Associate – Operations Coordinator

Job Requisition: REQ-10032267

This role provides operational and administrative support to the Regulatory Affairs team, including regulatory systems and databases, documentation, stakeholder coordination, procurement activities, records management, reporting, and compliance.

2. Regulatory Affairs Specialist – Labelling

Job Requisition: REQ-10032265

This position supports regulatory submission activities for ANZ, regulatory information management, artwork and labelling activities, submission tracking, dossier preparation, and coordination with internal and external stakeholders.

3. Regulatory Affairs Specialist – Submission Info Management

Job Requisition: REQ-10032268

This role focuses on regulatory submission information, Regulatory Information Management (RIM), lifecycle management, product registration information, regulatory databases, compliance tracking, and support for Australia and New Zealand regulatory activities.

Responsibilities

Regulatory Affairs Associate – Operations Coordinator

Key responsibilities include:

• Supporting the Director of Scientific Affairs with meetings, reports, newsletters, projects, and activities.
• Monitoring and disseminating regulatory correspondence through group inboxes.
• Managing health authority portal access and system administration.
• Processing invoices, purchase orders, vendor requests, and regulatory spend reconciliation.
• Managing purchase orders and invoice reconciliation for external vendors and service providers.
• Coordinating RLD sample procurement with global vendors and external partners.
• Maintaining regulatory records and departmental archiving.
• Maintaining regulatory databases and tracking platforms through Regulatory Information Management (RIM).
• Tracking ANZ submissions, approval status, and post-approval commitments.
• Supporting the review and maintenance of local WPs and SOPs.
• Assisting with dossier development and collation.
• Supporting KPI tracking, reporting, process improvement, audit readiness, and digital readiness.
• Providing input into Regulatory IT projects.
• Supporting continuous improvement and regulatory risk management activities.

Regulatory Affairs Specialist – Labelling

Key responsibilities include:

• Preparing variation submissions and artwork-related templates.
• Supporting artwork style guides for marketed dosage forms and product portfolios.
• Conducting second reviews of artwork briefs and updates.
• Maintaining regulatory submission information in RIM systems, trackers, and databases.
• Tracking ANZ submissions, approvals, and post-approval commitments.
• Reviewing submission and post-approval activity data.
• Supporting SOP and Working Procedure maintenance.
• Assisting with dossier development and collation.
• Maintaining traceable regulatory histories and accessible regulatory documents.
• Providing functional input on proposed regulatory changes.
• Supporting performance tracking and regulatory KPIs.
• Liaising with parent companies, license companies, and third parties for regulatory documentation and responses.
• Supporting artwork change requests and data maintenance.
• Coordinating updated artwork implementation with internal and external stakeholders.
• Generating artwork briefs for new submissions and variations.
• Supporting artwork approval system activities, including annotations, document uploads, reviews, and approvals.
• Contributing to continuous improvement, regulatory IT, audit readiness, and digital readiness.

Regulatory Affairs Specialist – Submission Info Management

Key responsibilities include:

• Maintaining high-quality regulatory submission information and data.
• Updating regulatory databases and tracking platforms through RIM.
• Tracking ANZ submissions, approval status, and post-approval commitments.
• Reviewing tracking metrics and identifying areas for improvement.
• Supporting SOP and Working Procedure management.
• Assisting with regulatory dossier development and collation.
• Maintaining traceable regulatory histories and regulatory documents.
• Providing functional input on regulatory actions and impacts.
• Supporting KPI and compliance reporting.
• Providing reports on variations, lifecycle projects, and business risks related to supply continuity and process improvement.
• Liaising with international parent and license companies and third parties for required documentation and responses.
• Supporting new registrations in other countries through timely requests for CoPPs.
• Supporting lifecycle management activities.
• Maintaining product information in RIM, including product specifications, labelling, shelf life, and storage conditions.
• Supporting artwork approval system activities.
• Keeping up to date with applicable regulatory requirements.
• Supporting Health Authority and industry consultation processes.
• Contributing to SOP/WI revisions and continuous improvement initiatives.

Eligibility and Qualifications

Common Eligibility

Candidates should meet the following requirements:

• Graduate with experience in the pharmaceutical industry.
• Minimum 2 years of industry experience desired.
• Strong attention to detail.
• Ability to prepare documents thoroughly.
• Ability to manage multiple projects simultaneously.
• Ability to change direction quickly when required.
• Ability to access information from multiple sources.
• Ability to support other members of the team.

Additional Requirement – Regulatory Affairs Specialist – Labelling

• Some knowledge of TGA and Medsafe requirements.

Regulatory Affairs Specialist – Submission Info Management

• Education: Graduate with pharmaceutical industry experience.
• Experience: Minimum 2 years industry experience desired.
• Language: English.

Required Skills

The job descriptions list the following desired skills:

• Clinical Study Reports
• Data Analysis
• Documentation Management
• Life Sciences
• Operational Excellence
• Regulatory Compliance

Regulatory Affairs Career Opportunities at Sandoz

The three openings cover different areas of Regulatory Affairs. The Operations Coordinator role has a strong focus on regulatory operations, administration, procurement, databases, records, and stakeholder support. The Labelling Specialist role focuses on regulatory submissions and artwork activities, while the Submission Info Management Specialist role focuses on RIM, submission data, lifecycle management, and regulatory information.

Application Details