Regulatory Team Lead, CMC Variations
Stiefel Laboratories, Inc
woj. wielkopolskie, Poland
8 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 all changes for Finished Product and Drug Substance are properly registered and up to date is essential, and that’s where our CMC Variations team is key.

The Regulatory CMC Variations team supports our portfolio of medicines by ensuring that the CMC information relating to the quality, safety and efficacy of our products is correct.

This is done through the creation and management of CMC Variation regulatory dossiers, which contains information related to the quality of Finished Product and Drug Substance.

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 CMC Variations dossiers created by you and your Team and ensuring continuity of supply for life saving medicines.

The Regulatory Team Lead reports to CMC Variations & Labelling Regulatory Manager and is accountable for leading and managing the team responsible for delivering CMC Variation dossiers for European and ROW markets in line with existing business needs, strategies, goals and objectives in order to support GSK’s product licenses worldwide.

Regulatory Team Lead cooperates with internal and external stakeholders 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,
  • continue to support CMC Variation projects by timely delivering high quality applications,
  • ensure high standard of submissions, act as quality control point,
  • 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,
  • monitor regulatory intelligence and act proactively on identified changes to regulatory requirements,
  • 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 CMC regulatory affairs,
  • capability to build and maintain a team,
  • bachelors degree in scientific or technical field,
  • fluent English and Polish (both verbal and written),
  • strong interpersonal and communication skills,
  • ability to perform multiple tasks, set the right priorities to deliver objectives on time,
  • adapting to changing circumstances through priorities reassessment and a disciplined, logical work style.
  • Preferred qualifications :

  • well developed leadership skills,
  • negotiation and problem solving skills,
  • practical knowledge of risk management,
  • Project Management experience would be an asset.
  • Why GSK? :

    GSK is deeply committed to professional and personal development offering employment opportunities across a diverse collection of businesses and geographies.

    So you’ll flourish in an inspiring environment where personal growth plays a vital part in the changing face of the business.

    Most of all, you’ll enjoy the sense of purpose that comes from leading change in an industry that touches millions every day.

    We offer :

  • Established job in one of the leading global healthcare companies.
  • Access to newest technologies and solutions.
  • Possibilities of development witihin the role and company’s structure.
  • Non-wage benefits (private medical healthcare, life insurance, sports card).
  • Free parking area and company canteen.
  • Work culture based on respect, honesty, transparency and focus on patient / consumer’s needs.
  • 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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