COMPLETE Regulatory Affairs Manager - Nordics (all gender) - EMEA, SE, Stockholms län, Danderyd, CSL Behring

In order to strengthen our Commercial Affiliate in Sweden, we are currently hiring a

Regulatory Affairs Manager - Nordics

to be located in Danderyd.

As a member of the CSL Behring Nordic Team, the Nordic Regulatory Affairs Manager is responsible for regulatory compliance, maintenance and expertise for all medicinal product registrations where CSL Behring is the local representative in the Nordic region.

Main responsibilities and accountabilities:

• You are part of a strong experienced team in the Quality, Regulatory Affairs and Pharmacovigilance department, and with support from Global functions
• You are responsible to manage, design and execute regulatory strategies for product portfolio and Life Cycle Management Submissions.
• You will provide guidance and oversee regulatory activities in support of timely submissions to ensure there are no interruptions in supply.
• You will oversee and manage company’s labeling documentation, adapt and modify according to national requirements, negotiate with agencies in order to obtain harmonized prescribing information/common Nordic labeling material. Coordinator of regulatory activities with local regulatory contactors and translators.
• You are an affiliate member of the European Regulatory Affairs team and act as the Nordic regulatory stakeholder management expert.
• You will provide regulatory and quality guidance into local management, commercial business teams and therapeutical area teams (e.g. on launch activities, tender applications, HTA applications, significant product changes, end-to-end labeling, marketing material).
• You will act as deputy Local Quality Officer working with fulfilling EU Good Distribution Practice (GDP) requirements defined in current local laws, HSLF-FS 2021:95 and later versions, according to the LQO delegate and CSL Behring global quality policies and procedures.
• You will support the Regional Safety Officer, in accordance with current PV regulations and company guidelines and SOPs.
• You will act professional and efficient to serve customers (internal and external) with high-quality information in a timely manner. Has strong self-leader and time efficiency skills.

Qualifications and Experience Required:

• University degree, preferably in pharmacy or natural sciences
• Minimum 10 years of regulatory experience in pharmaceutical companies, familiar with the regulatory environment in all Nordic countries.
• Preferred: Minimum of 5 years of experience as RP/QP working with fulfilling EU Good Distribution Practice (GDP) requirements.
• Experience working as project leader in cross functional teams driving implementation of new processes and new product registrations.
• Preferred: Experience with Medical Device and EU Medical Device Regulation.

Reporting relations:

Role that this position reports to: Head of Regulatory Affairs, Quality and Pharmacovigilance

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About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

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