Job Title: Regulatory Affairs Lead CEE
1 tydzień temu
About the Role
We are seeking a highly skilled Regulatory Affairs Manager CEE & CIS to join our team at TN Poland.
This role involves leading regulatory strategy development and execution for CIS and non-EU CEE countries, managing the entire registration process, and interacting with Health Authorities.
Key responsibilities include:
- Lead regulatory strategy development and execution for CIS and non-EU CEE countries.
- Manage the entire registration process, including new product approvals, manufacturing and import permits, and product amendments.
- Support distributors in interactions and negotiations with Health Authorities, driving an agenda to create a favorable regulatory environment.
- Provide strategic direction to the business, aligning regulatory strategies with business needs and goals.
- Maintain and manage regulatory files, documentation, and corporate electronic databases, ensuring compliance and up-to-date records.
Your Background
- At least 5 years of experience in a similar role, preferably in Regulatory Affairs.
- Fluency in Russian and proficiency in English.
- A strong understanding of regulatory frameworks, especially within the CIS – including Eurasian Economic Union framework - and non-EU CEE countries.
- Excellent communication and negotiation skills, with the ability to build effective relationships with Health Authorities and other stakeholders.
- Proven ability to manage complex projects and coordinate cross-functional teams.
- A high level of organization, attention to detail, and ability to work independently.
Our Culture
- We value diversity and inclusion, delivering better outcomes by reflecting the perspectives of our diverse customer base.
- We offer a competitive compensation package with bonus structure and extended benefit package.
- We provide a hybrid work culture that offers flexibility and autonomy.
- We empower employees to grow and take accountability through personalized career paths.
- We believe in ownership from day one, allowing employees to contribute and make a meaningful impact.
-
Regulatory Affairs Expert for CEE Market
1 tydzień temu
Warszawa, Mazovia, Polska TN Poland Pełny etatJob SummaryTN Poland seeks a highly experienced Regulatory Affairs Manager CEE & CIS to lead regulatory strategy development and execution for CIS and non-EU CEE countries.This role involves managing the entire registration process, interacting with Health Authorities, and maintaining regulatory files and documentation.Key responsibilities include:Lead...
-
Regulatory Affairs Specialist CEE
1 tydzień temu
Warszawa, Mazovia, Polska TN Poland Pełny etatCompany OverviewTN Poland is a dynamic organization that prides itself on embracing diversity and inclusion, delivering better outcomes by reflecting the perspectives of our diverse customer base.Job DescriptionThe Regulatory Affairs Manager CEE & CIS role at TN Poland involves leading regulatory strategy development and execution for CIS and non-EU CEE...
-
CEE Regulatory Manager Position
1 tydzień temu
Warszawa, Mazovia, Polska TN Poland Pełny etatOur ApproachAt TN Poland, we understand the importance of regulatory affairs in navigating the complex landscape of CIS and non-EU CEE countries.As a Regulatory Affairs Manager CEE & CIS, you will lead the development and execution of regulatory strategies, ensuring timely and high-quality submissions.This role involves managing the registration process,...
-
senior manager regulatory affairs
4 tygodni temu
Warszawa, Mazovia, Polska Randstad Pełny etat**Job Title:** Manager, Regulatory AffairsContribute to Global Development and Lifecycle ManagementYou will lead the development and execution of global CMC regulatory strategies, ensuring compliance with regulatory requirements and representing Global CMC Regulatory Affairs in cross-functional and external collaborations.About This Opportunity:This is an...
-
regulatory affairs manager
4 tygodni temu
Warszawa, Mazovia, Polska Randstad Pełny etatJob SummaryA highly skilled Regulatory CMC Manager is sought to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products. This individual will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development.Key...
-
Regulatory Affairs Expert
1 dzień temu
Warszawa, Mazovia, Polska Tomasz Rutkowski Solo Law Firm Pełny etat**About the Role:**We are seeking a highly skilled Regulatory Affairs Expert to join our team. As a key member of our regulatory department, you will play a crucial role in ensuring compliance with all applicable regulations and guidelines.In this position, you will be responsible for the preparation and submission of clinical trial applications (CTAs)...
-
Regulatory Affairs Coordinator
4 dni temu
Warszawa, Mazovia, Polska Johnson & Johnson Pełny etatJob SummaryWe are seeking an experienced Regulatory Affairs Coordinator to join our team.In this role, you will be responsible for ensuring that regulatory submissions are prepared and submitted in accordance with regulatory requirements.You will work closely with cross-functional teams to ensure that regulatory documents are accurate and complete.The ideal...
-
Regulatory Affairs Senior
4 tygodni temu
Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etatFor our Client, one of the biggest Pharmaceutical Companies worldwide, we are looking for a Regulatory Affairs Senior / Specialist in Submission Publishing who will be responsible for executing the electronic publishing of complex regulatory submissions for national, regional and global regulatory agencies and operating companies in both eCTD and non-eCTD...
-
Regulatory Affairs Specialist
4 tygodni temu
Warszawa, Mazovia, Polska TN Poland Pełny etatRegulatory Affairs SpecialistThis role involves handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA). It requires ensuring Regulatory Affairs compliance according to local legislation and Standard Operating Procedures (SOPs).Main Responsibilities:Prepare and submit Regulatory...
-
Specialist, Regulatory Affairs
4 tygodni temu
Warszawa, Mazovia, Polska TN Poland Pełny etatRegulatory Affairs Specialist Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Warsaw, Poland.Key Responsibilities:Prepare and submit regulatory documents, CTA packages, and submissions in assigned countries to ensure high quality standards.Coordinate regulatory timelines and deadlines for all assigned projects...
-
Specialist, Regulatory Affairs
2 dni temu
Warszawa, Mazovia, Polska TN Poland Pełny etatSocial network you want to login/join with:Specialist, Regulatory Affairs (Poland), WarsawClient:InderoLocation:Warsaw, PolandJob Category:OtherEU work permit required:YesJob Reference:0b22dd25b017Job Views:3Posted:21.03.2025Expiry Date:05.05.2025Job Description:Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In...
-
Regulatory Affairs Specialist
1 tydzień temu
Warszawa, Mazovia, Polska TN Poland Pełny etatAre you passionate about regulatory affairs and project management in the pharmaceutical industry?About UsTN Poland is a leading provider of pharmaceutical services, and we are seeking a dynamic Regulatory Affairs Associate to join our Labelling & Artwork team.About the Role: As a Regulatory Affairs Associate focusing on Secondary Packaging & Artwork, you...
-
Regulatory Affairs Specialist
2 dni temu
Warszawa, Mazovia, Polska TN Poland Pełny etatIndero, a contract research organization specialized in dermatology and rheumatology, is seeking a highly skilled Regulatory Affairs Specialist. As a key member of our team, you will be responsible for ensuring the quality and compliance of regulatory documents and submissions. This role requires strong knowledge of EU regional regulatory guidelines and...
-
Regulatory Affairs Specialist
2 dni temu
Warszawa, Mazovia, Polska TN Poland Pełny etatAt TN Poland, we are seeking a seasoned Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will play a critical role in ensuring compliance with complex regulatory issues and projects.Responsibilities:Provide consulting and advisory services for regulatory matters.Author and maintain documentation to sustain...
-
Poland Regulatory Job Opportunity
2 dni temu
Warszawa, Mazovia, Polska TN Poland Pełny etatWe are seeking an experienced EU CTR Expert to join our team in Poland. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the quality and compliance of regulatory documents and submissions. Your expertise in EU regional regulatory guidelines and ability to lead complex projects will be essential in driving business growth.\Your...
-
Warszawa, Mazovia, Polska TN Poland Pełny etatWe are seeking an experienced Senior Quality and Regulatory Affairs Manager to join our team in Warsaw, Poland. This role will be primarily located at Smith+Nephew's Warsaw office, with occasional travel to 3PL locations.As a Senior Quality and Regulatory Affairs Manager, you will lead a team of quality professionals and be responsible for developing,...
-
Regulatory Affairs Manager
1 tydzień temu
Warszawa, Mazovia, Polska TN Poland Pełny etatTN Poland is a global leader in clinical research services, and we are looking for a highly qualified Regulatory Affairs Manager to join our team. As a Senior Quality Assurance Auditor, you will be responsible for conducting audits that impact business operations, processes, and systems.The Regulatory Affairs Manager will have extensive experience in quality...
-
Regulatory Affairs Expert
1 tydzień temu
Warszawa, Mazovia, Polska TN Poland Pełny etatParexel, a leading Clinical Research Organization (CRO), is seeking an experienced Principal Regulatory Affairs Consultant to join their team in Warsaw. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval Chemistry, Manufacturing, and Controls (CMC) activities.This is a...
-
Regulatory Affairs Manager
2 tygodni temu
Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etatWe are seeking a highly skilled Regulatory CMC Manager to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products. In this position, you will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development. This...
-
Regulatory Affairs Specialist
6 dni temu
Warszawa, Mazovia, Polska GlaxoSmithKline Pełny etatJob Description:GSK is a global biopharma company that unites science, technology, and talent to get ahead of disease together. Our ambition is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.We are looking for a skilled Regulatory Affairs Specialist to join our team in Poland. As a key member...