With operations in 35+ nations and ~ 27,000 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!

For our Global Regulatory Affairs department we are looking for a

Senior Manager GRA Region Europe (f/m/d) - R-146685

(fulltime/ permanent/ non-tariff)

Main Responsibilities and Accountabilities
  • Serve as Senior Regulatory Regional Manager EU, to support product development and life cycle activities for the CSL Behring product portfolio
  • Contribute to the development of global regulatory strategies by providing expert knowledge on most efficient regional regulatory procedures and requirements
  • Strengthen global regulatory teams by providing expertise on regional regulatory guidelines and relevant Health Authority recommendations and assessments
  • Contribute to compilation of global and regional briefing packages for Health Authority meetings
  • Manage large projects or processes with limited oversight from manager
  • Contribute to the compilation of relevant high quality documentation for submissions in the region, including applications for new licenses, variations, license renewals, pediatric plans, orphan drug designations, product identifiers/names, and periodic reports according to agreed schedules
  • Drive management of regulatory procedures like new license applications, renewal applications, variation applications, period reporting submissions, submissions required to fulfill regulatory post approval commitments
  • Ensure data entry and timely updates of data entries into regulatory systems
  • Establish and maintain working relationship to Health Authorities by efficient communication and effective use of negotiation skills to achieve positive outcomes for CSL Behring
  • Organize and lead regional Health Authority interactions/meetings


Qualifications and Experience
  • A degree in Life Science (at least BSc), Medical Science, or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous.
  • At least 7 years of regulatory experience in a regulatory authority-facing role, supported by additional pharmaceutical / industry experience.
  • Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (relevant) regional Regulatory Authorities.
  • Strategic and tactical thinking ability, complemented by a "hands on" operational approach and business planning orientation.
  • Ability to identify the 'big picture' and opportunities/major issues and link day-to-day tasks with long-term goals.
  • Demonstrated ability to lead and influence.
  • Demonstrated sound judgment and flexible approach to managing situations with a strong Customer Service focus.
  • Highly effective communicator with written, verbal and presentation skills in English.


Worker Type:
Employee

Worker Sub Type:
Regular
Mission
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Senior Manager GRA Region Europe