Sandoz Hiring for Regulatory Affairs Submission Management

Sandoz is hiring for two Regulatory Affairs (RA) positions under its Submission Management team in Telangana. The openings are for RA Associate – Submission Management and RA Senior Associate – Submission Management.

Candidates with relevant experience in pharmaceutical, healthcare, regulatory affairs, and regulatory submission management can apply. Prior experience in Module 1 documentation and regulatory lifecycle management is preferred.

Both positions are full-time opportunities within Sandoz’s Region Europe Regulatory (RER) team, which manages regulatory affairs activities and marketing authorizations across Europe, Great Britain, and Switzerland.

Job Details

Available Positions

1. RA Associate – Submission Management

Apply for RA Associate – Submission Management

2. RA Senior Associate – Submission Management

Apply for RA Senior Associate – Submission Management

Job Responsibilities

Candidates selected for these Regulatory Affairs positions will support regulatory submission management and documentation activities, including:

• Prepare, compile, review, and maintain Module 1 documentation for variations, renewals, responses to Health Authority queries, and PSUR/PSUSA support activities.
• Support low-complexity new regulatory submissions and marketing authorization applications.
• Prepare and maintain regional administrative documents, including application forms, cover letters, certificates, and legal documentation.
• Conduct completeness, consistency, and compliance checks of Module 1 submission packages.
• Coordinate signatures, approvals, authorizations, and supporting documents from QA, Pharmacovigilance, Manufacturing, Regulatory Affairs, Legal, and country teams.
• Ensure correct document metadata, naming conventions, formatting, and version control.
• Maintain the lifecycle of Module 1 documents in electronic document management systems.
• Support country-specific administrative responses and clarification packages during regulatory validation and review.
• Maintain regulatory information for assigned products in relevant electronic information management systems.
• Support updates to regional administrative requirements, templates, and submission checklists.
• Participate in process improvement, standardization initiatives, and implementation of digital tools.
• Follow established regulatory procedures, guidance, and standard operating procedures.

Eligibility and Experience

Candidates should have relevant experience in one or more of the following areas:

• Pharmaceutical industry
• Healthcare
• Regulatory Affairs
• Regulatory Submission Management
• Module 1 documentation
• Regulatory lifecycle management

Prior experience working with Module 1 and lifecycle management is relevant to these positions.

Required Skills

• Basic knowledge of Regulatory Affairs processes.
• Strong attention to detail.
• Good documentation management skills.
• Quality-focused approach.
• Understanding of regulatory compliance and data integrity.
• Good Excel and Microsoft Office skills.
• Ability to work with structured data.
• Strong organizational and analytical abilities.
• Ability to collaborate within global teams.
• Good written and spoken English communication skills.
• Familiarity with eCTD/NeeS concepts.
• Knowledge of regional administrative requirements for at least one market or region is preferred.

Key Areas of Work

• Regulatory Submission Management
• Module 1 Documentation
• Regulatory Lifecycle Management
• Variations and Renewals
• PSUR/PSUSA Support
• Health Authority Responses
• Electronic Document Management
• Data Integrity and Compliance

RA Associate: Approximately 1–3 years of relevant experience.

RA Senior Associate: Approximately 3–5 years of relevant experience.