Regulatory Affairs Professional
4 tygodni temu
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.
- Liaise with internal departments and external partners to ensure regulatory compliance.
- Assist in the preparation and review of labeling, promotional materials, and other documentation.
- Prepare and submit regulatory documentation to health authorities – participation in the entire registration of a medicinal product in National and European (MRP/DCP) procedures for Poland and Baltics.
- Reviews submission documents and provide regulatory input (e.g., Variation, response documents, high level documents, regulatory maintenance documents/ aggregate safety report /PSUR, etc.).
- Execute and maintains the submission deliver plans, submissions content plan and proactively provide status updates to designated stakeholders.
- Identify regulatory risks and communicate mitigation to cross-functional team.
- Coordinates, plans, and prepares for submission the post-marketing or post approval applications i.e., variation/renewal/ other submissions activity.
- Perform QC of published sequences for Regulatory adequacy and eCTD aspects.
- Contributes and support for 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.
- Proficiency in English.
- Ability to work independently and as part of a team.
- Detail-oriented with a proactive approach to problem solving.
We offer opportunities for professional development and career growth, a supportive and collaborative work environment, and the chance to make a meaningful impact on public health.
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