Senior Regulatory Affairs Specialist

9 godzin temu


Warszawa, Mazovia, Polska 9605 GSK Services Sp z o.o. Pełny etat
Key Responsibilities:
  • Develop and refine the CTA/IND lifecycle strategy, ensuring timely content delivery and compliance with GSK policy and procedures.
  • Coordinate with the functional CTA/IND Team Lead to plan and deliver work plans, and with individual GRLs/TGs to manage study submission planning and delivery status.
  • Accountable for agreed tasks and projects, ensuring quality and timely delivery.
  • Communicate effectively with internal GSK staff to achieve assigned goals.
  • Ensure compliance with GSK systems and record keeping, and provide input to internal processes and written standards.
  • Work flexibly to meet shifting priorities and timelines, and provide support to other activities within the CTA/IND and/or Content Delivery Team.
Requirements:
  • Minimum Bachelor's degree in biological or healthcare science (Chemistry, pharmacy, or related science or regulatory affairs).
  • Relevant experience within Regulatory Affairs in the R&D, pharmaceutical industry, or clinical trials.
  • Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
  • Good understanding of Clinical Trial Directive, DIA Trial Master File Reference Model, and CTA/IND submission requirements for multiple countries/submission types.
  • Well-developed interpersonal and communication skills to work in a matrix environment effectively and build good working relationships in cross-functional teams.
  • Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.
  • Excellent organizational skills, attention to detail, and commitment to deliver high-quality output, even under pressure.
  • Ability to work in multiple IT systems (filing, tracking, and repositories).
  • Mentoring experience would be an advantage.
  • Veeva Vault experience would be an advantage.
What We Offer:
  • Career at one of the leading global healthcare companies.
  • Contract of employment.
  • Hybrid work arrangement (2/3 days per week from the office).
  • Attractive reward package (annual bonus and awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit).
  • Life insurance and pension plan.
  • Private medical package with additional preventive healthcare services for employees and their eligible dependents.
  • Sports cards (Multisport).
  • Possibilities of development within the role and company's structure.
  • Personalized learning approach (internal trainings, mentoring, access to online training platforms).
  • Extensive support of work-life balance (flexible working solutions, short Fridays option, health and well-being activities).
  • Supportive community and integration events.
  • Modern office with creative rooms and fresh fruits every day.


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