Project Director, Global Regulatory Affairs (100%) (m/f/d)

Location:Broadmeadows, Kankakee County, Montgomery County
Job Type:Full Time

About CSL

With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

CSL Behring – the global biotherapies provider driven by its promise to save lives and to improve the quality of life for people with rare and serious medical conditions.

For this global position (preferably located in Bern), we are looking for a

Project Director, Global Regulatory Affairs (100%) (m/f/d)

CSL’s Global Regulatory Affairs (GRA) department is currently looking for the new Project Lead of DIRECT-x, our current most important project aiming to fundamentally rethink our regulatory affairs capabilities.

Design and Implement Integrated Regulatory Capability (DIRECT-x) is a global transformation project relating to CSL’s regulatory capability in terms of processes, roles, responsibilities, systems and data. The aim of the project is to increase efficiency, transparency, employee and stakeholders’ satisfaction and to ensure compliance with new regulatory requirements and to support the substantial growth of the business. The project was initiated and is being managed by CSL’s Global Regulatory Affairs and includes a wide range of project participants from inside and outside of GRA representing all regulatory process parties as well as Business Technology.

Main Responsibilities and Accountabilities:

  • Fully responsible of the end to end project delivery lifecycle – from design, scoping and planning phase through deployment, training and hyper care including governance, planning, reporting, time management, resourcing, costs, closure, etc. Provides day-to-day leadership and direction to the Project, drive the pace & schedule of the project to time, cost and quality objectives.
  • Collaborates and engages with business stakeholders, sponsor and supporting functions to assure the project is well planned, implemented and closed. Assures that project is in position to move successfully through established portfolio and delivery gates, including collaborating on completion and accuracy of required documentation. Ensures that project management plans are maintained such as Communication, Risk, Cost, Resources, Contract, Change, Schedule, Scope and deliverables list, Benefit Realization plan.
  • Establishes project governance and management forums to execute successful project approvals and reviews. Assures effective and timely communication of projects status, issues, key risks, and opportunities, recommendation of appropriate risk mitigation strategies, contingencies, and actions to be taken including buy-in from stakeholders.
  • Manages, coordinates and integrates the work of multiple strategic external/internal partners to achieve project timelines and requirements.
  • Reviews and recommends for approval the overall project structure, method, approach and timelines.
  • Ensures project resources are effectively sourced, on-boarded, managed and off-boarded as per plan and forecast. Provides support to project management resources and serves as an escalation point for resource and project concerns to Project Sponsor.
  • Project vendor management accountability, including the development and approval of all contracts and statement of work with key vendors. Manages vendor relationship including variations review and approval, deliverables and payment approval.
  • Works in close relationship with Global Regulatory Affairs Business process Leaders, provides input in Regulatory Affairs processes and reviews the business deliverables.
  • Provide leadership and direction to the Business team when needed.

Qualifications & Experience:

  • Bachelor degree in business or technical field relevant to business process engineering and/or project management (MBA/advanced degree preferred).
  • Demonstrated success leading management of complex or multiple integrated projects requiring balancing stakeholders’ expectations.
  • Experience in regulatory Affairs within pharmaceutical/biotech/other highly regulated industry.
  • Extensive experience in Project Management in a demanding and a fast pace environment.
  • Experience in process management.
  • Project Management certification (PMP or IPMA) desirable; Lean six sigma or business process management certification is a plus.
  • Fluent written and spoken English, German skills would be an asset.

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.