Regulatory Labeling Senior Manager

4 tygodni temu


Warszawa, Polska ManpowerGroup Sp. z o.o. Pełny etat

Manpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i doświadczeniu. Skontaktuj się z nami - to nic nie kosztuje, możesz za to zyskać profesjonalne doradztwo i wymarzoną pracę


Job Tasks:
  • Lead the development, revision, review, agreement, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU Product Information (EUPI)), and derived documents (labeling text for EU, US) for assigned compounds
  • Make recommendations and provide advice and guidance about labeling content, processes, timelines, and scientific integrity. Coordinate the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation. Ensure high quality and compliant labeling documents
  • Contribute to and participate in the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area and their development plans and status and knowledge of labeling aspects for the development of labeling and target labeling
  • Contribute to the continuous improvement of the end-to-end labeling process
Requirements:
  • Minimum of 6 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance)
  • An understanding of pharmaceutical drug development
  • Experience in discussing and communicating scientific concepts
  • Understanding of worldwide regulatory guidelines and their applications for guidance for labeling
  • Experience leading project teams within a matrix environment, combined with the ability to work largely independently with limited supervision
  • English C1
Offer:
  • Opportunity to join a global team and work on global innovative projects
  • Option for 100% remote job within Poland
  • Work mainly in English within an international team
  • Attractive salary and benefits (option for a full time job or a freelance contract)

The offer applies to permanent work.

  • Warszawa, Mazovia, Polska TN Poland Pełny etat

    Social network you want to login/join with:Regulatory Labeling Senior Manager, WarsawClient:ManpowerLocation:Warsaw, PolandJob Category:OtherEU work permit required:YesJob Reference:9f311569cdfbJob Views:3Posted:21.03.2025Expiry Date:05.05.2025Job Description:Job Tasks:Lead the development, revision, review, agreement, and maintenance of primary labeling...


  • Warszawa, Mazovia, Polska TN Poland Pełny etat

    About the PositionWe are seeking an experienced Regulatory Labeling Senior Manager to join our team in Warsaw, Poland. This is a senior leadership position that oversees the development and maintenance of primary labeling for pharmaceutical products.Key ResponsibilitiesDevelop and maintain primary labeling, including the CCDS, USPI, and associated patient...


  • Warszawa, Mazovia, Polska TN Poland Pełny etat

    Job SummaryThis is a senior leadership position that oversees the development and maintenance of primary labeling for pharmaceutical products. The successful candidate will lead cross-functional teams and collaborate with external partners to ensure compliance with regulatory requirements.Key ResponsibilitiesLead the development and maintenance of primary...


  • Warszawa, Mazovia, Polska Randstad Pełny etat

    we are looking for a Senior Manager, Global Labelling to be responsible for the labelling strategy for pharmaceutical products in international markets. The role requires close collaboration with global and regional teams and subject matter experts to ensure documentation is in line with regulatory requirements and business strategy.the incumbent will manage...


  • Warszawa, Mazovia, Polska TN Poland Pełny etat

    About the RoleWe are seeking an experienced Regulatory Labeling Senior Manager to join our team in Warsaw, Poland.The successful candidate will be responsible for leading the development and maintenance of primary labeling for assigned compounds. This includes making recommendations on labeling content, processes, timelines, and scientific integrity. The...


  • Warszawa, Mazovia, Polska TN Poland Pełny etat

    Role OverviewThis senior manager position is responsible for overseeing the development and maintenance of primary labeling for pharmaceutical products. The successful candidate will lead cross-functional teams and collaborate with external partners to ensure compliance with regulatory requirements.Main ResponsibilitiesDevelop and maintain primary labeling,...


  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    We are looking for an experienced Senior Regulatory Affairs Professional to support the implementation of regional regulatory strategies for pharmaceutical products at various stages of their lifecycle. This role involves close collaboration with global and regional teams to effectively execute regulatory submission plans, support product approvals, and...


  • Warszawa, Mazovia, Polska JACOBS DOUWE EGBERTS Pełny etat

    Job DescriptionThe Scientific and Regulatory Affairs Specialist will oversee correct artwork elements, allergen labeling, and claims per JDE standards. You will advise R&D on compositional requirements, ingredient acceptability, and legal limits in recipes.This role requires strong communication skills and the ability to shape decision-making processes.

  • Regulatory Affairs Manager

    1 godzinę temu


    Warszawa, Mazovia, Polska IQVIA Pełny etat

    IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics, and human ingenuity to drive healthcare...


  • Warszawa, Mazovia, Polska Pfizer Pełny etat

    We are pleased to offer a Regulatory Compliance Specialist position at Pfizer's Worldwide Safety department in Poland-Warsaw.The successful candidate will have a strong background in pharmacovigilance, regulatory compliance, or a related field, with excellent communication and analytical skills. As a Regulatory Compliance Specialist, you will be responsible...


  • Warszawa, Mazovia, Polska Standard Chartered Life and Careers Pełny etat

    Job OverviewWe are seeking a highly skilled Regulatory Initiatives Manager to join our team at Standard Chartered Life and Careers.The successful candidate will be responsible for driving the delivery of CIB regulatory programs and initiatives, providing senior business analysis capabilities, and leading project management and change management efforts.This...


  • Warszawa, Mazovia, Polska IUX Pełny etat

    IUX is a leading fintech company revolutionizing the trading industry with cutting-edge technology and innovative financial solutions. We specialize in providing high-performance trading platforms, market analytics, and risk management tools to empower traders and financial institutions worldwide.At IUX, we foster a dynamic and international work environment...


  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    We 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...


  • warszawa, Polska Randstad Pełny etat

    Step into a pivotal role as Manager, Regulatory Affairs and contribute to the global development and lifecycle management of groundbreaking pharmaceutical products. As a key member of team, you will lead the development and execution of global CMC regulatory strategies, ensure compliance with regulatory requirements, and represent Global CMC Regulatory...


  • Warszawa, Mazovia, Polska TN Poland Pełny etat

    TN Poland is a Great Place to Work certified organization that recognizes the importance of employee retention and satisfaction. We are seeking a seasoned Regulatory Compliance Manager to join our team.Responsibilities:Develop and implement regulatory compliance programs.Conduct regulatory audits and risk assessments.Collaborate with cross-functional teams...


  • warszawa, Polska Randstad Pełny etat

    For our Client, one of the largest pharmaceutical companies in the world, we are looking for a Regulatory Affairs Manager who will manage the operational delivery of regulatory documents for product registration and compliance. This person will manage the team and coordinate the plans for packages of documents sent.If you have relevant experience and you are...


  • Warszawa, Mazovia, Polska Colgate Pełny etat

    Established in 1806 as a small soap and candle business in New York City, Colgate-Palmolive is now a truly global company with products sold in over 200 countries and territories under internationally recognized brand names such as Colgate, Palmolive, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, elmex, Tom's of Maine, Sanex, Ajax, Axion, Soupline, Haci...

  • Regulatory Affairs Senior

    4 tygodni temu


    Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    For 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...


  • warszawa, Polska Randstad Pełny etat

    We 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...


  • Warszawa, Mazovia, Polska Goldman Sachs Bank AG Pełny etat

    The Compliance Division plays a crucial role in preventing, detecting, and mitigating compliance, regulatory, and reputational risk across the firm. As an Associate in the Compliance Testing Group, you'll contribute to this effort by conducting reviews and investigations that cover various firm businesses and divisions.You'll propose methods of...