Site Activation and Regulatory Expert
4 days ago
We are seeking a highly skilled Site Activation and Regulatory Expert to join our team in the Nordics region.
The successful candidate will be responsible for performing tasks at a country level associated with Site Activation (SA) activities, ensuring adherence to local and international regulations, standard operating procedures (SOPs), project requirements, and contractual guidelines.
This is a home-based role that requires proficiency in the local language.
Key Responsibilities:
- Serve as Single Point of Contact (SPOC) for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments.
- Ensure adherence to SOPs, Work Instructions (WIs), quality of designated deliverables, and project timelines.
- Perform start-up and site activation activities according to applicable regulations, SOPs, and work instructions.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases, and tracking tools.
- Review and provide feedback to management on site performance metrics.
Requirements:
- At least 1 year of clinical research experience.
-
Copenhagen, Copenhagen, Denmark IQVIA LLC Full timeAbout the RoleThis is an exciting opportunity to join our team as a Regulatory Affairs Specialist for Site Activation in the Nordics region.You will be responsible for performing tasks at a country level associated with Site Activation (SA) activities, ensuring adherence to local and international regulations, standard operating procedures (SOPs), project...
-
Start-Up and Site Activation Coordinator
4 days ago
Copenhagen, Copenhagen, Denmark IQVIA Argentina Full timeAbout the RoleThis is an exciting opportunity to join our team as a Regulatory Compliance Specialist - Site Activation. As a key member of our Site Activation team, you will play a critical role in ensuring compliance with regulatory requirements, SOPs, and WIs. You will work closely with Site Activation Managers, Project Management teams, and other...
-
Regulatory Compliance Specialist
4 days ago
Copenhagen, Copenhagen, Denmark IQVIA Argentina Full timeJob OverviewThis is a Home-Based role that requires local language proficiency. The successful candidate will work independently, serving as the primary point of contact for investigative sites, ensuring adherence to SOPs, WIs, and quality deliverables. They will also be responsible for preparing site regulatory documents, performing quality control, and...
-
Regulatory Compliance Expert
6 days ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeJob DescriptionOur company is seeking a Regulatory Compliance Expert to join our Emerging Technologies API Manufacturing Development (ET API MDev) team. In this role, you will be responsible for ensuring compliance with GxP guidelines and regulations, supporting management in setting the direction for the department on quality challenges and...
-
Global Regulatory Strategy Expert
3 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout This OpportunityWe're looking for an experienced Global Regulatory Strategy Expert to join our team at Genmab. As a key member of our Global Regulatory Affairs organization, you'll play a critical role in developing and executing the EU/ROW regulatory strategy for assigned projects. Your expertise will be essential in ensuring regulatory compliance and...
-
Associate Director Regulatory Strategy
5 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleThe Associate Director, Global Regulatory Affairs Project Lead will play a critical role in our Global Regulatory Affairs organization. As an expert in regulatory affairs, you will be responsible for representing RA in the Clinical Trial Teams and ensuring regulatory oversight and progress of multiple clinical trial submission activities.You...
-
Regulatory and Start Up Specialist _ Nordics
4 days ago
Copenhagen, Copenhagen, Denmark IQVIA LLC Full timeRegulatory and Start Up Specialist - Nordics Apply locations: Solna, Sweden; Copenhagen, Denmark; Espoo, Finland; Oslo, Norway Time type: Full time Posted on: Posted 2 Days Ago Job requisition id: R1470460 Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international...
-
Nuclear Regulatory Oversight Expert
5 days ago
Copenhagen, Copenhagen, Denmark NTU International AS Full timeNTU International A/S is leading a consortium for the implementation of the EU funded project called: Strengthening Egyptian nuclear safety and radioprotection regulatory infrastructure and is searching for experts to support the core team during the implementation of this project. The overall objective of this action is to strengthen the nuclear safety...
-
Regulatory and Start Up Specialist _ Nordics
4 days ago
Copenhagen, Copenhagen, Denmark IQVIA Argentina Full timeJob Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.Home Based role and requires local language proficiency. ...
-
Regulatory and Start Up Specialist _ Nordics
5 days ago
Copenhagen, Copenhagen, Denmark IQVIA Argentina Full timeJob OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.Home Based role and requires local language...
-
Regulatory Affairs Expert
6 days ago
Copenhagen, Copenhagen, Denmark CareerArc Full timeCareerArc is seeking a seasoned Regulatory Affairs Expert to lead the development of our open banking business in Europe. As a key member of the Global Regulatory Team, you will play a critical role in shaping our strategy and ensuring regulatory compliance across multiple jurisdictions.About the RoleIn this role, you will advise on supervision and...
-
Regulatory Compliance Expert
5 days ago
Copenhagen, Copenhagen, Denmark AJ Vaccines Full timeJob SummaryWe are seeking a Regulatory Compliance Expert to join our Pharmacovigilance and Safety Team at AJ Vaccines. In this role, you will be responsible for ensuring that our operations are compliant with international regulations and guidelines.Key ResponsibilitiesEvaluate and manage global pharmacovigilance reportsDevelop and maintain SOPs and...
-
Regulatory Expert in Nuclear Safety
5 days ago
Copenhagen, Copenhagen, Denmark NTU International AS Full timeNTU International A/S is leading a consortium for the implementation of the EU funded project: Strengthening Egyptian nuclear safety and radioprotection regulatory infrastructure.The overall objective of this action is to enhance the nuclear safety and radioprotection regulatory framework of the Egyptian Nuclear and Radiological Regulatory Authority...
-
Regulatory Affairs Expert
1 day ago
Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full timeWe are seeking a dedicated and experienced Regulatory Affairs Manager to join our team at Oresund Pharma ApS.Job Description:The successful candidate will be responsible for developing and maintaining a global product portfolio following regulatory requirements and commercial demands. Key responsibilities include lifecycle management, ensuring products...
-
Regulatory Affairs Expert
1 day ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeAs a Regulatory Affairs Expert at Radiometer Danmark, you will play a critical role in ensuring compliance with applicable standards and regulations within the organization. You will be responsible for handling quality management systems and supporting processes, participating in and driving smaller projects in the RA/QA function with manageable risks and...
-
Regulatory Affairs Specialist
1 day ago
Copenhagen, Copenhagen, Denmark Sandoz International GmbH Full timeWe are looking for a new regulatory colleague for our life cycle management (LCM) Product team at Sandoz Nordic. Here, you will be responsible for our marketing authorisations for affiliate life cycle activities, of a defined portfolio.Here, you are given the opportunity to deep dive into the products and be the best sparring partner possible for your...
-
Global Regulatory Affairs Project Lead
5 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob OverviewWe are seeking a highly skilled and experienced Associate Director, Global Regulatory Affairs Project Lead to join our team at Genmab. In this role, you will be responsible for representing RA in the Clinical Trial Teams and ensuring regulatory oversight and progress of multiple clinical trial submission activities.You will work closely with the...
-
Product Regulatory Affairs Expert
5 days ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeWe are Radiobotics, a company driven by aspiration, curiosity, and playfulness. We strive to learn what happens beyond the surface and show up every day ready to engage and have fun with each other. Our vision is to solve the global need for radiologists while ensuring every patient receives expert-level care.As a Quality Management System Professional, you...
-
Director of Regulatory Affairs
6 days ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeThe Director of Regulatory Affairs ensures that the company's products meet global regulatory requirements, focusing on the USA and Europe, including those set by the FDA, EMA, and other relevant authorities. This role is responsible for developing and executing regulatory compliance strategies, navigating approval processes for pharmaceuticals and medical...
-
Site Manager Specialist
6 days ago
Copenhagen, Copenhagen, Denmark IQVIA Argentina Full timeAbout IQVIA ArgentinaWe are a leading provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. Our goal is to help our clients drive healthcare forward and improve patient outcomes.Job Description:The Site Manager Specialist will be responsible for managing and monitoring clinical trials at...