Sandoz Require Regulatory Affairs Specialist

Sandoz is a global leader in generic and biosimilar medicines, which are more affordable versions of brand-name drugs. The Swiss-based company was part of Novartis until October 2023 when it became an independent entity, and its products reach millions of patients worldwide. Sandoz also provides active pharmaceutical ingredients and has a portfolio of approximately 1,300 products, including over-the-counter medications and treatments for a wide range of conditions from cancer to the common cold.

Post : Regulatory Affairs Specialist – Submission Info Management

Job Description
1. Operational Efficiency
• Maintain high quality data management on regulatory submission information supported in line with priority and portfolio plan in partnership with Regulatory Affairs team. Accountable for accurate and timely entries into various local and global databases and tracking platforms to ensure compliance and knowledge management through Regulatory Information Management (RIM), reporting, tracking of ANZ submission, approval status and post-approval commitments.
• Ensure key submission and post approval activity data provided by RA is up to date and accurate. Ongoing review of tracking metrics to identify areas of improvement. Oversight of training and management of local Standard Operating Procedures (SOP) and Working Procedures (WP) for currency and effectiveness to ensure RA operations remain optimal and ensure compliance to support business objectives.
• Assist in the review and maintenance of local WPs and SOPs to refine processes and procedures in accordance with global SOPs. Assist the Regulatory Affairs Department in the development and collation of dossier including processes and procedures to deliver high-quality published submissions to meet HA requirements for an effective submission.
• Ensure systems and processes are in place to enable regulatory history for all applications is traceable and regulatory documents are easy to locate. Evaluates proposed changes and provides functional input and update for affiliate regulatory actions and impact.
• Contributes to performance tracking and KPIs of the team to deliver agreed targets and objectives and supports reporting. Provide regular reports for compliance status for variations and life cycle projects and risk to the business in terms of supply continuity, process improvement.
• Liaison with international parent and license companies, third parties for the acquisition of documentation, information and responses to issues raised during review/evaluation. Create and maintain databank of frequently asked questions to improve dossier quality. Update RIM to enable SMEs to provide quality and timely responses to Health Authority questions.
• Support new registrations in other countries by timely requests of CoPPs. Contribute to the Regulatory Affairs Department initiatives e.g. process improvements, implementation of new technologies, audit readiness, digital readiness Provide input on future Regulatory IT projects both on a local and global basis as required.

2. Internal stakeholder support
• Support the regulatory submissions team on life cycle management related activities with input from relevant Regulatory Affairs Associate to ensure continuity of product supply
• Ensure relevant stakeholders have current information on product details for registered products via RIM on product specifications, product labelling, shelf life and storage conditions for all products
• Liaise with local RA team and RGD and RGLI on relevant product details as reflected on RIM
• Support RA and Artwork teams with the execution of tasks within the artwork approval system, (generating annotations, upload documents, document review and document approval) as required

3. External Stakeholder Relationships
• Keep up to date with current regulatory requirements and how these affect the Sandoz product portfolio and disseminate to internal stakeholders as required
• Actively support with Health Authority and Industry consultation processes

4. Other Regulatory Work
• Contribute to continuous improvement activities such as revision of SOPs/WIs
• The position will also assist the Director of Scientific Affairs or their nominee on tasks as required.
• Keep up to date with current overseas, Australian and New Zealand regulatory requirements and how these affect the Sandoz pipeline and product portfolio
• Provide Regulatory strategies for internal projects, and continuous improvement via knowledge sharing.

Candidate Profile
• Cross Cultural Experience.
• 5+ years of relevant experience.
• Functional Breadth.
• Collaborating across boundaries.
• Operations Management and Execution.
• Project Management.
• Clinical Study Reports.
• Data Analysis.
• Documentation Management.
• Life sciences.
• Operational Excellence.
• Regulatory Compliance.

Additional Information
Education : Graduate with experience in pharmaceutical industry
Languages : English
Experience : Minimum of 2 years industry experience desired
Job ID : REQ-10032268
Location : Telangana (Sandoz)
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Research & Development
End Date : 15th November 2026