Sandoz Hiring for Regulatory Affairs Specialist – GMP

Sandoz is hiring a Regulatory Affairs Specialist – GMP for its Telangana location. The role focuses on GMP clearance applications, regulatory submissions, manufacturing site compliance, regulatory information management, and coordination with health authorities and internal stakeholders.

Candidates with a graduate degree and pharmaceutical industry experience can review the eligibility criteria and apply through the official Sandoz careers portal.

Job Details

Position: Regulatory Affairs Specialist – GMP

The selected candidate will provide operational and regulatory support for obtaining and maintaining GMP clearances for existing and new manufacturing sites while ensuring compliance with local and corporate requirements.

Key Responsibilities

• Prepare, submit, and maintain GMP clearance renewals for manufacturing sites, including applications to the Therapeutic Goods Administration (TGA).
• Coordinate with international parent companies, licence partners, third parties, and manufacturing sites to obtain regulatory documents and responses.
• Maintain accurate regulatory information in databases, trackers, and regulatory information management systems.
• Support TGA inspections of overseas manufacturing sites and coordinate related activities with relevant stakeholders.
• Coordinate GMP evidence verification for Medsafe-registered products.
• Support regulatory dossier preparation, submission documentation, and regulatory history management.
• Review and maintain standard operating procedures (SOPs) and work instructions.
• Track post-approval GMP commitments and support regulatory change management.
• Monitor regulatory requirements in Australia, New Zealand, and other relevant overseas markets.
• Contribute to process improvements, audit readiness, digital readiness, and regulatory IT initiatives.
• Ensure GMP clearances support product registrations, submissions, and supply continuity.

Eligibility and Qualifications

• Graduate degree with experience in the pharmaceutical industry.
• A minimum of 2 years of industry experience is desired.
• English language proficiency.

Required Skills

The job description highlights the following skills:

• Regulatory affairs and GMP compliance
• Regulatory submissions and documentation management
• Pharmaceutical industry knowledge
• Life sciences
• Data analysis
• Operational excellence
• Regulatory information management
• Stakeholder coordination
• SOP and work-instruction management
• Regulatory tracking and compliance reporting