Regulatory Affairs Specialist – Submission Info Management

Location: Telangana (Sandoz)

Job Description Summary

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

Provide effective operational and regulatory support to ensure compliance and regulatory submission activities for ANZ, effective regulatory reporting on submission, HA questions and approval status and follow on activities including continuous improvement in relation to standards, templates and pro-cedures. Regulatory Information Management (RIM) on relevant systems, trackers and databases for regula-tory submissions and commitments.

Support the team with life cycle management and registration information support for the Australia and New Zealand market to allow the best possible time frame for registration and launch/supply continuity.

Major Accountabilities

• 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.