Regulatory Affairs Professional

2 weeks ago


Copenhagen, Copenhagen, Denmark Sandoz International GmbH Full time

We are seeking a highly motivated and experienced Regulatory Affairs Professional to join our life cycle management team at Sandoz Nordic.

Company Overview

Sandoz, a leading global generics and biosimilars company, is committed to providing high-quality medicines to patients around the world. With a strong presence in over 100 countries, we strive to make a positive impact on people's lives while driving growth and innovation.

Job Description

In this role, you will be responsible for managing all life cycle activities for your defined portfolio, ensuring compliance with regulatory guidelines and providing guidance on national and EU legislation within the regulatory field. You will also work closely with Supply Chain/Planning/QA/QC and Global RA teams to drive business partnership and ensure seamless collaboration.

You will have the opportunity to work independently, plan, structure, and coordinate tasks within given timelines with an appropriate sense of urgency without undermining quality. We expect you to be a self-confident team player who can handle multiple tasks simultaneously and demonstrate excellent communication skills – written and verbal.



  • Copenhagen, Copenhagen, Denmark Hurecon Full time

    About the JobHurecon, a leading pharmaceutical company, is seeking an experienced Regulatory Affairs professional to join our team in Copenhagen. As a key member of our regulatory department, you will be responsible for maintaining and following up on global Marketing Authorizations on the European Market.Key Responsibilities:Maintain and follow up on global...


  • Copenhagen, Copenhagen, Denmark Sandoz International GmbH Full time

    We are seeking a Regulatory Affairs Specialist to join our Life Cycle Management (LCM) Product team at Sandoz Nordic.This role involves responsible for all life cycle management activities for your defined portfolio, ensuring regulatory compliance and collaborating with Supply Chain/Planning/QA/QC and Global RA teams.The ideal candidate will have a strong...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the PositionWe are seeking a highly skilled Regulatory Affairs professional to join our team as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will have the opportunity to utilize your expertise to drive regulatory compliance and quality in clinical trials.ResponsibilitiesDrive regulatory compliance and quality in...


  • Copenhagen, Copenhagen, Denmark Prolific Xpert Full time

    The Regulatory Affairs Consultant will play a crucial role in ensuring that our organization adheres to national and international legislation and guidelines regarding compliance and audits.Key DeliverablesDevelop policies and procedures for compliance and risk managementConduct regular training sessions for employees on compliance and risk...


  • Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full time

    Oresund Pharma ApS is a Nordic based privately owned specialty pharmaceutical company focusing on marketing value-added products in the European countries. We work with a large network of contract manufacturers, suppliers, wholesalers, and distributors, which provide us with a very dynamic, flexible, and scalable business structure.Our team consists of 4...


  • Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full time

    We are seeking a dedicated and experienced professional to join our Regulatory department as a Regulatory Affairs Manager. This role will be responsible for maintaining and developing a product portfolio following regulatory requirements and commercial demands.Key ResponsibilitiesEnsure timely delivery of regulatory plans in alignment with business...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Genmab A/S is dedicated to creating life-changing antibody therapeutics for patients with cancer and other serious diseases. As a Regulatora Affairs Strategist in our Global Regulatory Affairs organization, you will play a key role in shaping the regulatory strategy for our products.Your primary responsibility will be to support the Global Regulatory Lead...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking a highly skilled Associate Director, Global Regulatory Affairs Project Lead to join our team at Genmab. This individual will be responsible for representing RA in the Clinical Trial Teams and ensuring regulatory oversight and progress of multiple clinical trial submission activities.The successful candidate will work closely with...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job DescriptionWe are seeking a highly skilled and experienced Strategic Director of Regulatory Affairs to join our team at Genmab. In this role, you will be responsible for developing and implementing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.You will provide strategic input and...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Join Our TeamWe are seeking an experienced Regulatory Affairs professional to join our Global Regulatory Affairs organization as a Director, Global Regulatory Affairs Project Lead. The successful candidate will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects and ensuring regulatory oversight of clinical trial...


  • Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

    Innovative solutions for a better tomorrowRadiometer Danmark / Danaher is committed to improving global healthcare with reliable, fast, and easy patient diagnoses. We strive to make a difference in people's lives by providing cutting-edge technology and solutions.The Senior Manager, RA Processes, Systems and Tools plays a crucial role in driving process...


  • Copenhagen, Copenhagen, Denmark IQVIA Argentina Full time

    Job Title: Regulatory Affairs CoordinatorIQVIA Argentina is seeking a highly skilled Regulatory Affairs Coordinator to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements, providing training and support to sites, and collaborating with the study team to track the progress of assigned studies.Key...


  • Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full time

    We are seeking a dedicated and experienced Regulatory Affairs Manager.As part of our team, you will be responsible for Oresund Pharma's products worldwide with the purpose to develop and maintain a global product portfolio following regulatory requirements and commercial demands.As Regulatory Affairs Manager, you will be responsible for your own portfolio...


  • Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full time

    We are seeking a dedicated and experienced Regulatory Affairs Manager. As part of our team, you will be responsible for Oresund Pharma's products worldwide with the purpose to develop and maintain a global product portfolio following regulatory requirements and commercial demands. As Regulatory Affairs Manager, you will be responsible for your own...

  • Regulatory Affairs

    4 days ago


    Copenhagen, Copenhagen, Denmark Hurecon Full time

    Regulatory Affairs - National & EU proceduresHurecon Copenhagen, Capital Region of Denmark, DenmarkREGULATORY AFFAIRS – EU PROCEDURES - NORDIC LANGUAGE - REMOTE POSSIBLEDO YOU WANT:To use either your Danish, Swedish or Norwegian Language - together with your English language skills?To have the ability to work remote as your other colleagues within RA are...

  • Regulatory Affairs

    4 days ago


    Copenhagen, Copenhagen, Denmark Hurecon Full time

    Regulatory Affairs - National & EU procedures Hurecon Copenhagen, Capital Region of Denmark, Denmark REGULATORY AFFAIRS – EU PROCEDURES - NORDIC LANGUAGE - REMOTE POSSIBLE DO YOU WANT: To use either your Danish, Swedish or Norwegian Language - together with your English language skills? To have the ability to work remote as your other colleagues within...


  • Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time

    We are looking for a highly skilled Regulatory Affairs Professional to join our team at Radiobotics. As a key member of our Clinical and Regulatory department, you will play a crucial role in maintaining superior product quality and driving growth into new markets. Your main tasks will include co-driving product release projects, supporting other departments...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Our CultureGenmab fosters a culture of collaboration, mutual respect, and open communication. Our team is composed of talented individuals who share a passion for innovation and excellence. We strive to create an environment where every employee feels valued, supported, and empowered to contribute to our shared success.About the PositionWe're seeking a...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    We're dedicated to creating life-changing treatments at Genmab, and we're seeking a highly skilled Biopharmaceuticals Regulatory Affairs Specialist to join our Regulatory Affairs CMC team.Director/Associate Director, Global Regulatory Affairs - CMCIn this critical role, you will be responsible for providing regulatory CMC input to support worldwide...


  • Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

    Get AI-powered advice on this job and more exclusive features.Senior Business Development Consultant at Black Swans ExistDirector of Regulatory AffairsAre you ready to take on a pivotal role in shaping the future of women's health? Our client, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health, seeks a...