Oferta pracy

Regulatory Specialist, Clinical Trial Application Submission Coordination

GSKO firmie

GSK

Adgar Wave

Warszawa

Global Regulatory Platform and Delivery (GRPD) in GlaxoSmithKline is a regulatory affairs function which brings together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, license maintenance and lifecycle management dossiers and regulatory information management. GRPD provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity).

Step up to the new challenge and take the lead in a diverse international regulatory environment. Bring a real value to our Patients worldwide by having a high level of impact on delivery of the early and late-stage pipeline.

The Job holder works with the Team Manager to ensure that appropriate content for specific submissions supporting R&D projects is developed and delivered to agreed timeframes and in compliance with GSK processes and policies as they apply to the role.

 

Regulatory Specialist, Clinical Trial Application Submission CoordinationNumer ref.: 270909

Responsibilities:

  • Responsible for: coordination, development, refinement of the CTA lifecycle strategy, timely content & delivery appropriate to each individual regulatory agency, while maintaining compliance with GSK policy and procedures.
  • Accountable to the Team Manager for overall work plans, accountable to individual GRLs/TGs for study submission planning & delivery status.
  • Accountability for agreed tasks and projects.
  • Ensures independent communication, with a range of internal GSK staff, in supporting achievement of the assigned goals.
  • Ensures quality of both own and submission team’s work, delivering to agreed timeframes, including compliance with GSK systems and record keeping.
  • Provides input to internal processes and written standards.
  • Works flexible in order to meet constant shifting priorities and timelines.
  • May provide support to other activities within the CTA and/or Content Delivery Team.
  • Good understanding of Clinical Trial Directive, DIA TMF Reference Model and CTA submission requirements for multiple countries/submission types.

Preferred Experience:

  • Bachelor’s degree or higher in biological or healthcare science.
  • Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
  • A good understanding of Clinical Trial Directive and CTA submission requirements for multiple countries/submission types.
  • Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
  • Ability to interpret and advise on guidelines and requirements on a global basis.
  • Ability to build effective working relationships and work in a matrix environment effectively.
  • Ability to work in a matrix environment and ensure delivery of objectives across cross-functional teams.
  • Ability to gain consensus on a way forward in an environment, where there may be more than one way of achieving a successful outcome.
  • Ability to think flexibly in order to meet constantly shifting priorities and timelines.
  • English language skills.
  • Knowledge of drug development and manufacturing and supply processes.
  • Knowledge of worldwide regulatory requirements.
  • Service orientation, customer-focused, goal-oriented.

We offer:

  • Important and interesting job in one of the leading global healthcare companies.
  • Possibility to work with engaged and enthusiastic people from various locations.
  • Access to newest technologies and solutions.
  • Possibilities of development within the role and company’s structure benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, flexible working hours, home office).
  • Corporate culture based on our values: patient focus, integrity, respect and transparency.

 
Poznan Business Garden, Poland

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