Regulatory Affairs Specialist – Submission Info Management

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.

Job Description

Major Accountabilities

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.

Ideal Background

Education: Graduate with experience in pharmaceutical industry

Languages: English

Experience: Minimum of 2 years industry experience desired

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!

Join us, help us make healthcare fairer and faster.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#Sandoz

Skills Desired

Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory Compliance