For our Global Regulatory Affairs department we are looking for a
Regulatory Regional Manager EU (m/f)
(full-time / permanent)
Main Responsibilities and Accountabilities
- Serve as Regulatory Regional Manager EU, for one or more programs/projects and participate in global regulatory teams, as applicable.
- Develop and document regional regulatory strategies considering regional requirements, classification of changes, scheduling and priority setting.
- 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 while taking into account regional specific requirements. This comprises also related responses to questions on the submissions.
- Lead the preparation and contribute to briefing packages for Health Authority meetings.
- Responsible for the management of regulatory procedures like new license applications, renewal applications, variation applications, period reporting submissions, submissions required to fulfill regulatory post approval commitments and Scientific Advice meetings in the region.
- Act as a Subject Matter Expert on regional, regulatory procedures and Health Authority requirements
- Develop and maintain effective working relationships with regional Health Authorities demonstrated by efficient communication and effective use of negotiation skills to achieve positive outcomes for CSL Behring.
Qualifications / experience
- A degree in Life Science (at least BSc) or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous.
- At least 5 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.
- Understanding of the principles of GMP, GCP and GLP.
- 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 ability to deal with rapid change.
- Demonstrated sound judgment and flexible approach to managing situations.
- Customer service focus.
If you are interested in this challenging position, please apply via our website.
CSL Behring GmbH
Position number: R-072750
Worker Sub Type:Regular
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