Regulatory Affairs Professional
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.
- 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.
-
Regulatory Affairs Professional
3 tygodni temu
Warszawa, Mazovia, Polska SC Johnson Professional Pełny etatRegulatory Affairs Role OverviewThe Regulatory Affairs team at SC Johnson Professional is seeking a highly motivated and detail-oriented individual to support the development and implementation of regulatory strategies for our products in Central Europe.Key Responsibilities:Maintain the Safety Data Sheets database for all productsSupport new product...
-
Regulatory Affairs Professional
2 tygodni temu
Warszawa, Mazovia, Polska SC Johnson Professional Pełny etatIntern, Regulatory AffairsAs a Regulatory Affairs Professional at SC Johnson Professional, you will have the opportunity to gain valuable work skills and experience through assigned tasks.Responsibilities:Maintain the Safety Data Sheets database for all productsNew product development for local marketsMaintain legal compliance of existing productsMonitor...
-
Regulatory Affairs Professional
2 tygodni temu
Warszawa, Mazovia, Polska RICG Poland Sp. z o.o. Pełny etatRegulatory Affairs Specialist RoleWe 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...
-
Regulatory Affairs Intern
3 tygodni temu
Warszawa, Mazovia, Polska SC Johnson Professional Pełny etatOverviewThe Regulatory Affairs Intern role at SC Johnson Professional offers a unique opportunity to gain hands-on experience in product compliance and regulatory affairs. As an intern, you will be responsible for maintaining the Safety Data Sheets database for all products, supporting new product development for local markets, and ensuring legal compliance...
-
Regulatory Affairs Professional
1 tydzień temu
Warszawa, Mazovia, Polska RICG Poland Sp. z o.o. Pełny etatKey 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,...
-
Regulatory Affairs Specialist
3 tygodni temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etatRegulatory Affairs Support OpportunityWe are seeking a highly skilled Regulatory Affairs Support professional to join our international Regulatory Affairs Team at an international pharmaceutical company.Key Responsibilities:Provide Regulatory Affairs support with the assembly, transmission, storage, and handling of regulatory information.Enter document...
-
Regulatory Affairs Specialist
3 tygodni temu
Warszawa, Mazovia, Polska RICG Poland Sp. z o.o. Pełny etatRegulatory Affairs SpecialistWe 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:Regulatory Compliance: Ensure compliance with Polish and European regulations for pharmaceutical products.Liaison and Communication: Liaise with internal departments...
-
Regulatory Affairs Specialist
3 tygodni temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etatRegulatory Affairs SupportWe are seeking a highly skilled Regulatory Affairs Support professional to join our international Regulatory Affairs Team. As a key member of our team, you will be responsible for providing regulatory support with the assembly, transmission, storage, and handling of regulatory information.Key Responsibilities:Enter document metadata...
-
Regulatory Affairs Specialist
3 tygodni temu
Warszawa, Mazovia, Polska RICG Poland Sp. z o.o. Pełny etatRegulatory Affairs SpecialistWe 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...
-
Regulatory Affairs Expert
3 tygodni temu
Warszawa, Mazovia, Polska Parexel Pełny etatParexel's Expertise in Regulatory AffairsWe are seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for biological products and/or vaccines.The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth...
-
Regulatory Affairs Specialist
2 tygodni temu
Warszawa, Mazovia, Polska Novo Nordisk Pełny etatAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Novo Nordisk. As a key member of our Regulatory Affairs and Pharmacovigilance Team, you will be responsible for handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA).Main...
-
Regulatory Affairs Specialist
3 tygodni temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etatRegulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our international Regulatory Affairs Team. As a key member of our team, you will be responsible for providing Regulatory Affairs support, ensuring compliance with regulatory requirements, and maintaining accurate records.Key Responsibilities:Provide Regulatory...
-
Regulatory Affairs Specialist
4 dni temu
Warszawa, Mazovia, Polska Novo Nordisk Pełny etatJob Description:Novo Nordisk is seeking a highly skilled Regulatory Affairs Specialist to join our team in Poland. As a key member of our Regulatory and Pharmacovigilance Team, you will be responsible for handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA). Your main responsibilities...
-
Regulatory Affairs Specialist
3 tygodni temu
Warszawa, Mazovia, Polska Novo Nordisk Pełny etatJob Title: Regulatory Affairs SpecialistAbout the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Novo Nordisk. As a key member of our Regulatory Affairs and Pharmacovigilance Team, you will be responsible for ensuring compliance with local legislation and Standard Operation Procedures (SOPs) for our medicinal products...
-
Regulatory Affairs Specialist
3 tygodni temu
Warszawa, Mazovia, Polska Parexel Pełny etatParexel is seeking a Regulatory Affairs Associate (Labelling) to support our team.The successful candidate will be responsible for managing and coordinating text and artwork changes, ensuring compliance with regulatory requirements and global labeling standards.Key Responsibilities:Track the status of ongoing changes to labelling/artwork projects, evaluating...
-
Regulatory Affairs Expert
2 tygodni temu
Warszawa, Mazovia, Polska Parexel Pełny etatParexel is seeking a highly qualified Regulatory Affairs Expert with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval CMC activities.This role involves serving as a Project Leader, providing...
-
Regulatory Affairs Specialist
2 tygodni temu
Warszawa, Mazovia, Polska Novo Nordisk Pełny etatJob SummaryAs a Regulatory Affairs Specialist at Novo Nordisk, you will be responsible for handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA).Key Responsibilities:Preparing and submitting Regulatory documentation for New Drug Applications, post-marketing variations and renewal...
-
Regulatory Affairs Specialist
3 tygodni temu
Warszawa, Mazovia, Polska ManpowerGroup Sp. z o.o. Pełny etatRegulatory Affairs ProfessionalManpower Group Sp. z o.o. is a global company with over 70 years of experience, operating in 82 countries. We have been present on the Polish market since 2001 and currently have almost 35 branches across the country. Our goal is to provide candidates with new opportunities, help them find a job that matches their...
-
Regulatory Affairs Specialist
4 dni temu
Warszawa, Mazovia, Polska Parexel Pełny etatWork with Us to Shape the Future of Clinical ResearchParexel, a leading Clinical Research Organization, is currently seeking a skilled and detail-oriented Regulatory Affairs Associate (Labelling) to join our team.As a Regulatory Affairs Associate, you will be responsible for managing and coordinating text and artwork changes, ensuring compliance with...
-
Regulatory Affairs Specialist
2 tygodni temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etatRegulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our international Regulatory Affairs Team. As a key member of the team, you will be responsible for coordinating lifecycle management procedures, ensuring timely submission of high-quality dossiers, and managing validation issues.Key Responsibilities:Coordinate...