Oferta pracy

Labelling Regulatory Manager

GSKO firmie

GSK

Grunwaldzka 189

Poznań

At GSK, we’re constantly developing new products and improving our established medicines to improve the quality of human life by enabling people to do more, feel better and live longer.  Ensuring these products are correctly prescribed and used is essential, and that’s where our Labelling team is key.  The Regulatory Labelling team supports our portfolio of medicines by ensuring that the information relating to the safety and efficacy of our products reaches patients and prescribers. This is done through the creation and management of Product Information (Labelling), which contains information for prescribers and patients.
 
Respond to a challenge and take a lead in a diverse international regulatory environment.  In this role you have an opportunity to make a positive impact on GSK Patients worldwide delivering Labelling documents and data created by you and your Team. 
 
The Labelling Regulatory Manager reports to CMC Variations & Labelling Senior Regulatory Manager and is accountable for leading and managing the team responsible for delivering local labelling submissions and management of global labelling documents in line with existing business needs, strategies, goals and objectives in order to support GSK’s product licences worldwide. Labelling Regulatory Manager cooperates with colleagues in clinical, safety and other regulatory functions according to agreed ways of working, priorities and deadlines to ensure delivery of overall Departmental goals.
Labelling Regulatory ManagerNumer ref.: 268006

In your new role as the Labelling Regulatory Manager you will:

  • manage people aspects of a team of direct reports to create and sustain an efficient and motivating working environment
  • support global/country/regional labelling in compliance with GSK Labelling processes and external requirements
  • act as subject matter expert in GSK Labelling process
  • identify risks to quality and/or timely completion of project, resolving any issues and escalating items to be resolved at a higher management level
  • participate in projects and activities, such as identifying areas for improvements/efficiencies and leading implementation of changes to labelling processes
  • build and maintain quality relations with your internal and external stakeholders
  • work closely with your peers and manager to drive standardization across the business

Basic qualifications:

  • min. 3 years of experience in regulatory area, labelling experience is preferred
  • higher education in life sciences/ pharmacy
  • sound understanding of pharmaceutical industry, drug development environment and regulatory processes
  • well-developed understanding of labelling (e.g. significant experience in managing local labelling documents/submissions and/or management of global labelling documents)
  • strong interpersonal and communication skills and ability to present information in a clear and concise manner
  • ability to perform multiple tasks, set the right priorities to deliver objectives on time
  • adaptable to changing circumstances through priorities reassessment and a disciplined, logical work style
  • fluent English and Polish (both verbal and written)

Preferred qualifications:

  • well-developed leadership skills
  • negotiation and problem solving skills
  • project management and team management experience would be an asset

We offer:

  • Interesting job in one of the leading global healthcare companies.
  • Access to newest technologies and solutions.
  • Possibilities of development within the role and company’s structure.
  • Friendly work environment and great atmosphere in our teams.
  • Wide offering of company benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, recognition awards for additional achievements, flexible working hours, home office).
  • Corporate culture based on our values: patient focus, integrity, respect and transparency.
 
 

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