Regulatory Affairs Specialist

4 tygodni temu


Warszawa, Mazovia, Polska RICG Poland Sp. z o.o. Pełny etat
Regulatory Affairs Specialist

We are seeking a highly motivated Regulatory Affairs Specialist to join our team at RICG Poland Sp. z o.o. in a dynamic pharmaceutical company.

Key Responsibilities:
  • Ensure compliance with Polish and European regulations for pharmaceutical products, including the preparation and review of labeling, promotional materials, and other documentation.
  • Liaise with internal departments and external partners to ensure regulatory compliance, identifying and mitigating regulatory risks.
  • Prepare and submit regulatory documentation to health authorities, including participation in the entire registration of a medicinal product in National and European (MRP/DCP) procedures for Poland and Baltics.
  • Review submission documents and provide regulatory input, executing and maintaining submission deliver plans, submissions content plan, and proactively providing status updates to designated stakeholders.
  • Coordinate, plan, and prepare for submission the post-marketing or post-approval applications, including variation/renewal/other submissions activity.
  • Perform QC of published sequences for Regulatory adequacy and eCTD aspects, contributing and supporting regulatory operational activities.
Requirements:
  • Master's degree in Life Sciences, Pharmacy, or a related field.
  • Minimum of 1-2 years of experience in regulatory affairs within the pharmaceutical industry.
  • Knowledge of Polish and European pharmaceutical regulations.
  • Strong organizational and communication skills, with proficiency in English.
  • Ability to work independently and as part of a team, with a detail-oriented and proactive approach to problem-solving.
We Offer:
  • Opportunities for professional development and career growth.
  • A supportive and collaborative work environment.
  • The chance to make a meaningful impact on public health.
  • Employment contract or B2B.

If you are passionate about regulatory affairs and eager to contribute to our mission of delivering high-quality pharmaceutical products, we would love to hear from you.



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