Position Description Summary
Acts as the operational interface for both pharmacovigilance (PV) and regulatory affairs teams ensuring technology platform design delivery and operations support safety compliance and submission needs. This role will focus on optimizing platforms to streamline PV and regulatory processes ensuring alignment with global standards and regulatory requirements.
Main Responsibilities & Accountabilities
* Serve as point of contact for both PV and regulatory platform design delivery and operations
* Manage platform implementations updates and optimization of system solutions for regulatory document management registration tracking compliance management submission publishing and safety case processing
* Oversee the setup integration and ongoing governance of PV and regulatory platforms
* Own and manage the PV and regulatory platform roadmap ensuring it meets the evolving safety regulatory and compliance requirements. Responsible for lifecycle management governance release planning and operational health for these platforms
* Build and maintain strong relationships with regulatory and PV business stakeholders ensuring their requirements are captured and prioritized in platform design and process optimization.
* Lead cross-functional collaboration with clinical IT and external regulatory bodies to enhance platform adoption and submission efficiency
* Manage platform optimization to support continuous compliance efficiency and scalability across both PV and regulatory domains
* process improvements and ensure that both PV and regulatory platforms are fully aligned with business and regulatory needs
* Partner with the R&D and Enterprise Data Automation and AI teams to advance the digital capabilities to transform the R&D Operating model
Qualifications & Experience Requirements
Bachelors or Masters in Life Sciences Regulatory Affairs Health Informatics or related field
12 years of experience in pharmacovigilance regulatory affairs R&D operations or platform management
Expertise in safety data systems regulatory submission processes and platform technologies (e.g. Veeva Regulatory and Safety Argus Safety Solutionsetc.)
Proven leadership in managing cross-functional teams projects and vendor relationships
Strong knowledge of global regulatory requirements (e.g. FDA EMA MHRA) and safety data systems
Experience in PV system audits and inspections
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits from health care to financial protection so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family need help paying for emergency back up care or summer camp looking for mental health resources planning for your financial future or supporting your favorite charity with a matching contribution CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see whats available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL.
Do work that matters at CSL Behring!
Key Skills
* FDA Regulations
* Management Experience
* Manufacturing & Controls
* Biotechnology
* Clinical Development
* Clinical Trials
* Drug Discovery
* Project Management
* Filing
* Team Management
* Leadership Experience
* Chemistry
Employment Type
Full-Time
Vacancy
1
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