Regulatory Affairs Specialist
6 dni temu
Regulatory Affairs Specialist
We 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 lifecycle management procedures in-scope of the team and other regulatory procedures
- Ensure timely submission of high-quality dossiers
- Manage validation issues and prepare response documents
- Perform all country-specific activities as described in the country requirements database
- Perform all lifecycle management activities by following department's processes
Requirements:
- A minimum of a University degree or equivalent by experience
- At least 3 years of regulatory affairs experience
- In-depth knowledge of local and regional regulations/legislation
- Experience in regulatory lifecycle management and in co-operation with HAs
What We Offer:
- Employment contract for 12 months with the possibility of extension
- Hybrid work (2 days a week remote work)
- Benefits package: medical care, multisport card, life insurance
- Work in an international environment
-
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 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
2 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
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
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 our team, you will be responsible for ensuring compliance with regulatory requirements and ensuring the quality of our data.Key Responsibilities:Enter regulatory data into relevant systems and ensure...
-
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 team. As a key member of our Regulatory Affairs Team, you will be responsible for ensuring compliance with regulatory requirements and ensuring the quality of our data.Key Responsibilities:Enter regulatory data into relevant systemsTrack and...
-
Regulatory Affairs Specialist
2 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
2 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 Specialist
4 dni temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etatJob DetailsWe are seeking a skilled Regulatory Affairs Specialist to join our international team at Randstad Polska.About the RoleThe ideal candidate will have experience in regulatory affairs data management within the pharmaceutical or cosmetics industry. Strong knowledge of English and Polish is essential, with a good understanding of pharmaceutical...
-
Regulatory Affairs Specialist
1 tydzień 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
1 tydzień temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etatAre you looking for a challenging role in the pharmaceutical industry? We are seeking a highly skilled Regulatory Affairs Specialist to join our international Regulatory Affairs Team.Key responsibilities:Perform regulatory data entry activitiesTrack incoming data entry requests and follow up until completionEnter data in relevant systems based on information...
-
Regulatory Affairs Specialist
2 tygodni temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etatWe are seeking a highly skilled Regulatory Affairs Specialist to join our international team at Randstad Polska. The ideal candidate will have experience in a similar position in the pharmaceutical or cosmetics industry and a higher education degree.Key Responsibilities:Regulatory Affairs data entry activitiesTrack incoming data entry requests and follow up...
-
Senior Regulatory Affairs Specialist
2 tygodni temu
Warszawa, Mazovia, Polska Allegro sp. z o.o. Pełny etatSenior Regulatory Affairs SpecialistAllegro Group is seeking a highly skilled Senior Regulatory Affairs Specialist to join our Regulatory Affairs team focused on Poland and the CEE region. In this role, you will play a critical part in shaping legislation, including postal, customs, logistics, and tax laws, as well as AI and tech-related legislation.Key...
-
Regulatory Affairs Specialist
2 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
2 tygodni temu
Warszawa, Mazovia, Polska PL18 Alcon Polska Sp. z o.o. Company Pełny etatAbout the RoleWe are seeking a highly skilled Regulatory Affairs Analyst to join our team at Alcon Polska Sp. z o.o. Company. As a key member of our Regulatory Affairs EMEA team, you will play a critical role in supporting our administrative tasks, ensuring seamless coordination of payment and approvals for invoices, managing suppliers and contracts, and...
-
{"text":"Regulatory Affairs Specialist
1 dzień temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etat{"text":"Job Title: Regulatory Affairs Specialist (Pharmaceutical Industry)Are you looking for a role that combines your passion for regulatory affairs with your experience in the pharmaceutical industry?We are currently seeking a Regulatory Affairs Specialist to join our team at Randstad Polska.Employment contract for 12 months with the possibility of...
-
Regulatory Affairs Specialist
2 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 Expert
1 dzień temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etatJob DescriptionIntroductionRandstad Polska is seeking an experienced Regulatory Affairs Specialist to join their international Regulatory Affairs Team. The successful candidate will be responsible for coordinating lifecycle management procedures and ensuring timely submission of high-quality dossiers.Key ResponsibilitiesCoordinate lifecycle management...
-
Regulatory Affairs Specialist
2 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 Professional
1 tydzień 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 Specialist
2 tygodni temu
Warszawa, Mazovia, Polska Allegro sp. z o.o. Pełny etatRole OverviewAllegro sp. z o.o. is seeking a dedicated Regulatory Affairs Specialist to monitor, analyze, and engage with EU and Polish legislation related to product safety, sustainability, and consumer empowerment for the green transition.Key ResponsibilitiesAnalyze legislation in the area of sustainability and product safety to share insights with...