Associate Director, PV & Reg Platform
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Job Location:
Maidenhead - UK
Monthly Salary:
Not Disclosed
Posted on:
01-11-2025
Vacancies:
1 Vacancy
Job Summary
CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
Position Description Summary
The Associate Director PV & Reg Platform supports the execution and operational delivery of PV and regulatory platforms ensuring that system features align with business needs and compliance obligations. Assists with platform optimization issue resolution and cross-functional coordination.
Main Responsibilities
- Manage platform configuration testing and release planning for safety and regulatory systems.
- Support delivery of platform enhancements and ensure alignment with user needs.
- Collaborate with PV regulatory and IT teams to coordinate system upgrades and integrations.
- Monitor platform performance and contribute to the development of improvement plans.
- Assist in vendor coordination and service management to maintain compliance standards.
- Track platform KPIs and inspection readiness support documentation.
Qualifications and Experience Requirements
- Bachelors or Masters in Life Sciences Regulatory Affairs Health Informatics or related field.
- 10 years of experience in PV operations regulatory systems or R&D digital operations.
- Working knowledge of global regulatory processes and safety systems (e.g. Argus Vault RIM).
- Strong project coordination and documentation skills.
- Experience supporting audits or inspections is a plus.
Our Benefits
We encourage you to make your well-being a priority. Its important and so are you. Learn more about how we care at CSL.
About CSL Behring
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!
Required Experience:
Director
Key Skills
- Program assessment
- FDA Regulations
- Manufacturing & Controls
- Program Evaluation
- budget forecast
- Research Experience
- Operations Management
- Research & Development
- Strategic Planning
- Contract Management
- Leadership Experience
- negotiation
About Company
Join the thousands of people who safely donate plasma each week at CSL Plasma and get rewarded for your time.
