id: MTAwMDAwMDAxNTA1NTExOSA0MQ

reference: 1000000015055119

documentId: 1000000015055119

connectionPointId: 41

Názov práce: Farmaceuti

Popis práce:
Job Purpose
•    Leadership of Regulatory activities, strategy and compliance for pharma and vaccines product portfolios in Czech Republic & Slovakia
•    The development and implementation of standardized, efficient and compliant processes across the 2 markets and support to the cluster head.
•    Line management, coaching and development of a team or Regulatory staff across 2 markets
•    Be an authority on the regulatory framework in Czech Republic & Slovakia (with support from local point of contact as required) and Europe to provide guidance to the local business to ensure compliance and support commercial growth

Key Responsibilities
•    Lead regulatory strategy for Portfolio to underpin the Pharmaceutical business in Czech Republic and Slovakia to support competitive license approvals, market access, product launch and supply continuity.
•    Leadership of regulatory affairs activities for product portfolio in Czech Republic and Slovakia to enable the delivery of business priorities and maintain highest standards of regulatory compliance and quality
•    Dual reporting to cluster and LOC GMs. Advise LOC Management Teams (MT) on Regulatory matters and support MT business strategy.
•    Builds, maintains and leads an efficient and well-motivated team ensuring appropriate prioritization and flexible resourcing including driving and measuring performance
•    Leads the resource management, objective setting and review, development and coaching of staff.
•    Ensure the development and optimization of standardized, efficient and compliant processes across the Czech Republic and Slovakia.
•    Ensure compliant management of marketing authorizations.
•    Ensure regulatory documentation are maintained according to internal procedure.
•    Ensure local responsibilities relating to regulatory conformance are adhered to Regulatory Lead at audits and inspections
•    Develop and maintain strong relationships with all key personnel within the Regulatory Agencies Local Industry groups and with key internal groups including those at a senior level in Global Regulatory, Safety and Medical.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2262

abstractJV_contact_0:
, , lenka.x.kubicarova (at) gsk.com, lenka.x.kubicarova (at) gsk.com Lenka Kubičárová

requiredEducationLevelCode: 7

positionTypeCode: temporary

Meno zamestnanca: GlaxoSmithKline Slovakia s.r.o.

source: ISSZ