Regulatory Affairs Specialist
2 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, 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.
- 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.
- 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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