Regulatory Affairs Specialist – GMP

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 evaluate, submit and maintain GMP clearanc-es for existing and new manufacturing sites in the best possible time frame and to ensure compliance with all corporate and local requirements.
Partner with relevant stakeholders to assist in achieving optimal company outcomes.
Regulatory Information Management (RIM) on relevant systems, trackers and databases for regula-tory submissions and commitments.

Job Description

1. Stakeholder Relationships

• Preparation, submission and maintenance of GMP clearance renewals to the Therapeutic Goods Administration (TGA) 6 months prior to expiry date, where applicable, for existing and new manufacturing sites.
• Liaison with international parent and license companies, third parties for the acquisition of documentation, information and responses to issues raised during review/evaluation of submitted GMP clearance applications
• Accountable for accurate and timely entries into various local and global databases and tracking platforms including health authority digital horizon scanning to support stakeholder visibility and planning of variations; QA oversight of release conditions and noncompliance risk
• Support TGA inspections of overseas manufacturing sites by coordinating with the TGA, manufacturing sites, and licence partners, ensuring fulfilment of HA sponsor obligations; coordinate reimbursement of inspection-related invoices with licence partners
• Perform all activities as required to support regulatory and quality assurance team regarding QA agreements, launch support and product supply continuity
• Coordinate biannual GMP evidence verification for Medsafe-registered products. Provide GMP clearance support to third parties (LoAs) as required. 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 GMP 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.
• 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.
• Ensure GMP clearances are in place to support submission and market viability of all registered products
• GMP clearance applications are submitted on time and are accepted by the TGA

• Regulatory submissions are submitted in accordance with global/local procedures. Regulatory submissions information is updated and archived in accordance with global and local filing and archiving SOP; ARTG details reflect registered details

• Local and global stakeholders are kept updated on progress of GMP clearance application, in order to support product supply as defined by customer feedback and compliance with local best practice

• Post-approval GMP commitments are adequately tracked, communicated and completed. Regulatory input for databases is provided to enable effective change management
• 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

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