Regulatory Affairs Associate - Operations Coordinator

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!
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 administrative support to the Regulatory Affairs team by maintain-ing regulatory systems, databases and documentation to ensure compliance, data integrity and effi-cient business operations.
Support the team through inbox management, meeting coordination, training support, event
administration, and stakeholder engagement to ensure regulatory activities are executed accurately,
efficiently, and in accordance with internal procedures and health authority requirements.

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

1. Internal Stakeholder Relationships

• Assist the Director of Scientific Affairs with meetings, activities, reports, newsletters and projects as required. Monitor and disseminate group inbox for regulatory correspondence.
• Manage health authority portal access and other system administration. Ensure timely processing and payment of invoices for Regulatory Affairs, including raising POs and new vendor requests and reconciling regulatory spend with BPA
• Create, process, and manage purchase orders for external vendors and service providers, incl invoice reconciliation, and compliance with company procurement and financial procedures. Ensure timely reconciliation of department purchasing card statements for Regulatory Affairs department
• Oversee end-to-end RLD sample procurement activities, coordinating orders and deliveries with global vendors and external partners. Oversee regulatory records management, including maintaining departmental archiving records and assist team members with requests to send or recall items from off-site archiving
• 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
• 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.
• Contributes to performance tracking and KPIs of the team to deliver agreed targets and objectives and supports reporting. 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. 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. Achieve all deliverables outlined and assigned by the Director of Scientific Affairs and Regulatory Affairs Team in a timely manner
• 100% accuracy for all correspondence generated. Regulatory submissions information is updated and archived in accordance with global and local filing and archiving SOP;
• Regulatory input for databases is provided to enable effective change management. Post-approval commitments are adequately tracked, communicated, and completed
• Objectives and timelines of assigned departmental projects are met. Active participation in departmental meetings. Appropriate level of sharing on expertise and knowledge
• Active contribution to HA and industry consultation processes. Develop and implement local strategies to manage regulatory risk
  

What you’ll bring to the role:

Essential Requirements:

• Graduate with experience in pharmaceutical industry
• Minimum of 2 years industry experience desired. Strong attention to detail; thorough preparation of documents.
• Ability to work on multiple projects simultaneously and change direction quickly.
• Demonstrate ability to access information from multiple sources.
• Ability to support other members of the team.

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