Regulatory Affairs Specialist

4 miesięcy temu


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 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.
  • The chance to make a meaningful impact on public health.
  • Employment contract or B2B

If you are passionate about regulatory affairs and eager to contribute to our mission of delivering high-quality pharmaceutical products, we would love to hear from you



  • 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 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 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 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 myGwork Pełny etat

    Job Title: Medical Device Regulatory Affairs LeadThis role is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. We are looking for a highly skilled Regulatory Affairs Consultant to lead our medical device regulatory efforts.Key Responsibilities:Serve as Device Regulatory Lead on...


  • 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...


  • Warsaw, Polska myGwork Pełny etat

    This job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. We are looking for a Regulatory Affairs Consultant - Medical Device Regulatory Lead for Alliance Combination Products will oversee key regulatory activities and report to...


  • 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...


  • 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....

  • Intern, Regulatory Affairs

    5 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 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...

  • 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 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 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 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...

  • 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...


  • Warsaw, Polska AstraZeneca Pełny etat

    Working with the Processes Directors, taking responsibility for the management of assigned AstraZeneca projects, processes including implementation, communication, compliance, performance and inspection readiness. Specifically for this role the focus is intended to be CMC variation process and CMC contribution to overall Regulatory Business Processes. ...

  • Business Consultant

    4 tygodni temu


    Warsaw, Polska myGwork Pełny etat

    Regulatory Advisory SpecialistCapco, an inclusive employer and a member of myGwork, is seeking a highly skilled Regulatory Advisory Specialist to join our team. As a specialist in regulatory frameworks, you will provide expert guidance on PSD3 and payments-related regulations, ensuring clients meet industry compliance standards.Key Responsibilities:Provide...

  • 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...