Regulatory Affairs Professional
4 tygodni temu
Regulatory Affairs Specialist Role
We are seeking a highly motivated individual with a background in Polish and European regulatory law to support our team in delivering high-quality pharmaceutical products.
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.
- 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, we would love to hear from you.
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