Senior Manager, PV & Reg Platform

CSL Plasma; Maidenhead; On-site; GBP 70,000 - 90,000; Full time

Job summary

A global biotherapeutics leader in Maidenhead seeks a Senior Manager PV & Reg Platform responsible for providing operational support for pharmacovigilance and regulatory activities. The role includes system configuration, user engagement, and issue tracking, ensuring timely delivery of services. Candidates should have a Bachelor's degree in Life Sciences and at least 7 years of relevant experience, including Management and Project Management expertise. Competitive benefits offered.

Qualifications

• 7 years of experience in pharmacovigilance or regulatory systems support.
• Strong attention to detail and ability to manage multiple tasks across teams.
• Experience supporting validation and compliance documentation.

Responsibilities

• Support day-to-day operations of PV and regulatory platforms.
• Help document requirements and support user acceptance testing.
• Coordinate with IT and business stakeholders to resolve platform issues.

Skills

Program Management

FDA Regulations

Management Experience

Facilities Management

Clinical Development

Data Management

Quality Systems

Project Management

Research & Development

GLP

Budgeting

Leadership Experience

Education

Bachelor’s degree in Life Sciences, Health Informatics or related field

Tools

PV databases

Argus

Veeva RIM

Job description

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration we’re 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 Senior Manager PV & Reg Platform provides operational support for PV and regulatory platform activities including system configuration, user engagement and issue tracking. Ensures timely and compliant delivery of platform services to end users.

Main Responsibilities

• Support day-to-day operations of PV and regulatory platforms including system access, data entry, validation and reporting needs.
• Help document requirements and support user acceptance testing for new features or enhancements.
• Coordinate with IT and business stakeholders to resolve platform issues or change requests.
• Maintain platform documentation and support compliance reporting as needed.
• Track user feedback and support training initiatives to improve system usability.

Qualifications and Experience Requirements

• Bachelor’s degree in Life Sciences, Health Informatics or related field.
• 7 years of experience in pharmacovigilance or regulatory systems support.
• Familiarity with PV databases and regulatory platforms (e.g. Argus, Veeva RIM).
• Strong attention to detail and ability to manage multiple tasks across teams.
• Experience supporting validation and compliance documentation.

Key Skills

• Program Management
• FDA Regulations
• Management Experience
• Facilities Management
• Clinical Development
• Data Management
• Quality Systems
• Project Management
• Research & Development
• GLP
• Budgeting
• Leadership Experience

Employment Type: Full-Time

Experience: years

Vacancy: 1

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

Inclusion & Belonging

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 about Inclusion and Belonging at CSL.

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, 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 the ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company CSL headquartered in Melbourne, Australia employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.

Manager Platform • Maidenhead, England, UK