Regulatory Affairs Manager CEE

6 miesięcy temu


Warsaw, Polska Galderma Pełny etat

Description

Key Responsibilities

Lead regulatory strategy development and execution for CIS and non-EU CEE countries, ensuring timely and high-quality submissions. 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.

Skills & Qualifications

At least 5 years of experience in a similar role, preferably in Regulatory Affairs. Fluency in Russian and proficiency in English. 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. High level of organization, attention to detail, and ability to work independently.

What we offer in return

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will receive a competitive compensation package with bonus structure and extended benefit package You will be able to work in a hybrid work culture You will participate in feedback loops, during which a personalized career path will be established You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability

Next Steps

If your profile is a match, we will invite you for a first virtual conversation with the recruiter. The next step is a virtual conversation with the hiring manager  The final step is a panel conversation with the extended team

Our people make a difference

At Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.



  • Warsaw, Polska Allegro sp. z o.o. Pełny etat

    Job DescriptionAllegro Group is seeking two Senior Regulatory Affairs Specialists to join our Regulatory Affairs team focused on Poland and the CEE region. In this role, you will be instrumental in shaping critical legislation, including postal, customs, logistics, and tax laws, as well as the AI and tech-related legislation. You will monitor legislative...


  • Warsaw, Polska Haleon Pełny etat

    Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of...


  • Warsaw, Polska Novo Nordisk Pełny etat

    The position As a Regulatory Affairs Specialist, you will be responsible for handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA). You will ensure Regulatory Affairs compliance according to local legislation and Standard Operation Procedures (SOPs). Your main responsibilities will...


  • Warsaw, Polska Danaher Corporation Pełny etat

    Wondering what’s within Beckman Coulter Diagnostics? Take a closer look. At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates...

  • Regulatory Affairs Support

    2 miesięcy temu


    Warsaw, Polska Randstad Polska Pełny etat

    Currently, for our client, an international company from the pharmaceutical industry, we are looking for a person to join the international Regulatory Affairs Team. what we offeremployment contract for 12 months with the possibility of extensionhybrid work (2 days a week remote work)benefits package: medical care, multisport card, life insurancework in an...


  • Warsaw, Polska Randstad Polska Pełny etat

    Currently, for our client, an international company from the pharmaceutical industry, we are looking for a person to join the international Regulatory Affairs Team. what we offeremployment contract for 12 months with the possibility of extensionhybrid work (2 days a week remote work)benefits package: medical care, multisport card, life insurancework in an...

  • Regulatory Affairs Expert

    1 miesiąc temu


    Warsaw, Polska Allegro sp. z o.o. Pełny etat

    Job DescriptionJoin Allegro in our mission to ensure product safety, enforce anti-counterfeit policies, and promote sustainability! We are seeking a dedicated professional to monitor, analyze, and engage with EU and Polish legislation related to product safety, sustainability, and consumer empowerment for the green transition. You will play a crucial role in...


  • Warsaw, Polska Randstad Polska Pełny etat

    Currently, for our client, an international company from the pharmaceutical industry, we are looking for a person to join the international Regulatory Affairs Team. what we offeremployment contract for 12 months with the possibility of extensionhybrid work (2 days a week remote work)benefits package: medical care, multisport card, life insurancework in an...


  • Warsaw, Polska RICG Poland Sp. z o.o. Pełny etat

    Are you a dedicated Regulatory Affairs Specialist looking to advance your career in a dynamic pharmaceutical company? We are seeking a highly motivated individual with a background in Polish and European regulatory law to join our team.Key Responsibilities:Ensure compliance with Polish and European regulations for pharmaceutical productsLiaise with internal...

  • Intern, Regulatory Affairs

    6 miesięcy temu


    Warsaw, Polska SC Johnson Professional Pełny etat

    Intern, Regulatory Affairs Assistant to Regulatory and Registration Manager Location: Warsaw Overview The purpose of an internship is to provide real-world experience that enables the intern to put everything he/she learned into action. An internship can help the candidate gain skills that can be applied to future jobs. As an Intern,...


  • Warsaw, Polska Innovaderm Research Pełny etat

    The Associate Director, Regulatory Affairs is responsible for managing and overseeing the services provided by the Regulatory Affairs group in the assigned regions, and to ensure they are conducted according to Innovaderm’s standard operating procedures, applicable regulations and good clinical practices and to the Sponsor’s satisfaction....


  • Warsaw, Polska PL18 Alcon Polska Sp. z o.o. Company Pełny etat

    At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...

  • Medical Affairs Manager

    3 miesięcy temu


    Warsaw, Polska EssilorLuxottica Group Pełny etat

     WHO WE ARE:We are EssilorLuxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses. The Company brings together the complementary expertise of two industry pioneers, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that...

  • Brand Manager CEE

    6 miesięcy temu


    Warsaw, Polska Spin Master Ltd Pełny etat

    Job Description : What will you work on? As the Brand Manager you will be responsible for Brand Management plans, maximizing opportunities, managing risk, delivering on profitability goals, developing effective long-term business relationships, and exceeding customer expectations. How will you create impact? As the Brand Manager for CEE region,...


  • Warsaw, Polska Zimmer Biomet Pełny etat

    JOB DESCRIPTION At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.  As a Zimmer Biomet team member, you will share in our commitment to providing...


  • Warsaw, Polska Amazon Support Services Poland Sp. z o.o. - L97 Pełny etat

    Are you passionate about bringing connectivity to underserved customers? Do you want to work in a dynamic team building, launching and operating a satellite service for consumers from the ground up? The Project Kuiper Europe Consumer Business is looking for a talented individual to lead the CEE consumer business. This role is responsible for launching,...


  • Warsaw, Polska Boston Scientific Pełny etat

    Additional Locations:  N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...


  • Warsaw, Polska Stryker Polska Sp.z o.o. Pełny etat

    Work Flexibility: Hybrid We are creating the role of Manager Government Affairs and Market Access to support our continuous growth in Polish market. At Stryker, Government Affairs and Market Access function integrate the fields of access/reimbursement, advocacy, and policy to support our growth and help achieve the company’s mission. This position is a...

  • Director Regulatory Process

    6 miesięcy temu


    Warsaw, Polska AstraZeneca Pełny etat

    Act as Regulatory Process Lead, to lead their nominated area within Regulatory Processes. Regulatory Nominated Areas Include: Clinical Trials, License Maintenance, Marketing Application and Regulatory Information a Management. Responsiilities include: Design, development, implementation, maintenance, continuous improvement and ongoing customer support for...


  • Warsaw, Polska Haleon Pełny etat

    Hello. We’re Haleon.A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep...