Regulatory Team Lead, Labelling
Stiefel Laboratories, Inc
woj. wielkopolskie, Poland
6 d. temu

Your Responsibilities :

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 Regulatory Team Lead reports to CMC Variations & Labelling 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.

Regulatory Team Lead 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.

In your new role as the Regulatory Team Lead 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
  • drive continuous process improvement within areas of your influence
  • 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 and 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)
  • bachelor’s degree in life sciences
  • fluent English and Polish (both verbal and written)
  • strong interpersonal and communication skills and ability to present information in a clear and concise manner
  • capability to build and maintain a team
  • 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
  • Preferred qualifications :

  • well-developed leadership skills
  • negotiation and problem solving skills
  • project Management experience would be an asset
  • Why GSK? :

    Closing date for applications : 31 August 2018

    When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.

    Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.

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