Regulatory Affairs Professional

2 tygodni temu


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

Key Responsibilities:

  • Ensure compliance with Polish and European regulations for pharmaceutical products, including submission of regulatory documentation to health authorities.
  • Liaise with internal departments and external partners to ensure regulatory compliance and maintain the submission deliver plans.
  • Assist in the preparation and review of labeling, promotional materials, and other documentation, ensuring regulatory adequacy and eCTD aspects.
  • Prepare and submit regulatory documentation for the registration of medicinal products in National and European procedures for Poland and Baltics.
  • Review submission documents and provide regulatory input, including Variation, response documents, high-level documents, and regulatory maintenance documents.

Requirements:

  • A 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, with 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 proactive approach to problem-solving.

We Offer:

  • Opportunities for professional development and career growth in a dynamic pharmaceutical company.
  • A supportive and collaborative work environment.
  • The chance to make a meaningful impact on public health through the delivery of high-quality pharmaceutical products.


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