Senior Regulatory Specialist

1 week ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time

We are seeking a Senior Regulatory Specialist to join our dynamic Regulatory Affairs CMC team at Genmab A/S.

As a Senior Regulatory Specialist, you will be responsible for providing operational and strategic regulatory CMC input to support worldwide development and commercialization.

You will work closely with cross-functional teams to ensure compliance with regulatory requirements and provide guidance on EU, US and selected worldwide regulatory legislation for CMC topics.

Key responsibilities include:

  • Developing and executing sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle
  • Collaborating with cross-functional peers to facilitate and optimize product development
  • Planning, reviewing and preparing CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages

A strong understanding of compliance and biologics is essential, as well as experience with preparation of BLAs and lifecycle management.



  • Copenhagen, Copenhagen, Denmark Tampa Gardens Senior Living Full time

    Tampa Gardens Senior Living is seeking a skilled Senior IT Infrastructure Specialist to join our team. As a key member of our IT department, you will play a crucial role in ensuring the smooth operation of our IT systems.About the RoleThe Senior DevOps Consultant will be responsible for managing our IT infrastructure, including servers, networks, and...


  • Copenhagen, Copenhagen, Denmark MasterCard Full time

    Senior Counsel, Regulatory AffairsSenior Counsel, Regulatory AffairsApply locations Copenhagen, Denmark time type Full time posted on Posted 22 Days Ago job requisition id R-242297Our PurposeMastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy where...


  • Copenhagen, Copenhagen, Denmark MasterCard Full time

    Our PurposeMastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy where everyone can prosper. We support a wide range of digital payments choices, making transactions secure, simple, smart, and accessible. Our technology and innovation, partnerships,...


  • Copenhagen, Copenhagen, Denmark Hays Specialist Recruitment Full time

    Job Title: Senior Cyber Security Specialist LeadWe are seeking an experienced Senior Cyber Security Specialist Lead to lead our efforts in developing and implementing robust cyber security solutions for our clients.About the JobThis role requires a strong understanding of security architectures and systems in IT and OT environments.You will be responsible...


  • Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

    In this challenging role as Regulatory Compliance Specialist, you will be responsible for ensuring that our products comply with regulatory requirements. Your expertise in regulatory affairs will be instrumental in driving product releases and maintaining our QMS.Key responsibilities include staying up-to-date with changing regulatory requirements, adapting...


  • Copenhagen, Copenhagen, Denmark Danske Bank Full time

    Job OverviewDanske Bank is seeking a Senior Analyst to join its Business Controls and Product Management (BCPM) department. The successful candidate will play a key role in implementing and executing an effective 1st Line of Defence controls management framework, focusing on Regulatory Risk areas.The BCPM department supports the business in achieving...


  • Copenhagen, Copenhagen, Denmark Hays Specialist Recruitment Full time

    FreelanceprojektDenmarkStartdato: så hurtigt som muligtReferencenummer: 780901/1OpgaverWe are seeking a highly skilled and experienced Senior Cyber Security Compliance Specialist for our Client. In this role, you will be responsible for ensuring that our embedded software and OT systems meet all relevant security and compliance standards. You will work...


  • Copenhagen, Copenhagen, Denmark Sandoz International GmbH Full time

    We are seeking a highly skilled Regulatory Compliance Specialist to join our Life Cycle Management (LCM) Product team at Sandoz International GmbH. As a key member of our team, you will be responsible for ensuring the regulatory compliance of marketing authorizations across multiple countries and product portfolios.This role requires close collaboration with...


  • Copenhagen, Copenhagen, Denmark MasterCard Full time

    About the JobWe are seeking a highly experienced Regulatory Affairs Lawyer to join our team in Copenhagen, Denmark. As Senior Counsel for Open Banking, you will play a key role in shaping Mastercard's open banking strategy in Europe.Key ResponsibilitiesRegulatory Strategy: Help develop and implement Mastercard's open banking strategy in Europe.Regulatory...


  • Copenhagen, Copenhagen, Denmark NTU International AS Full time

    Key ResponsibilitiesAs Senior Nuclear Energy Consultant, you will be responsible for managing multinational teams and working experience in an EU regulatory body and/or its TSO would be an asset. Key responsibilities include:Leading the core team during the project's implementation;Contributing to the development of a strong nuclear safety and...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    We are looking for a highly skilled GxP Regulatory Compliance Specialist to join our team at Genmab A/S. In this role, you will be responsible for ensuring that our quality management systems and testing processes comply with relevant regulatory requirements.About the RoleYou will work closely with cross-functional teams to develop and implement quality...


  • 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 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 Eupry Full time

    Eupry is a leader in temperature monitoring solutions for GxP industries, ensuring compliance with regulatory requirements. As a dedicated and detail-oriented Regulatory Compliance Specialist, you will support our mission of delivering high-quality, compliant solutions.Key Responsibilities:Maintain and continuously improve our Quality Management System (QMS)...


  • Copenhagen, Copenhagen, Denmark NTU International AS Full time

    NTU International A/S is leading a consortium to strengthen the nuclear safety and radioprotection regulatory infrastructure of the Egyptian Nuclear and Radiological Regulatory Authority (ENRRA). As a key expert, you will support the core team during the implementation of this EU-funded project.Key ResponsibilitiesProvide expertise in nuclear safety and...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    We're on a mission to revolutionize cancer treatment at Genmab, and we're looking for talented professionals like you to help us achieve our goal.Director/Associate Director, Global Regulatory Affairs - CMCThis is an exciting opportunity for a seasoned Senior CMC Regulatory Expert to join our dynamic team and contribute to the development of innovative...


  • Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full time

    Job DescriptionThis role is a unique opportunity to join our team as a PV Specialist and contribute to maintaining oversight of the pharmacovigilance system. As a key member of our team, you will play a central role in managing and overseeing our global PV regulatory intelligence function.Your primary responsibility will be assessing and interpreting new...


  • Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

    Job Overview:This is a mid-senior level full-time position requiring a strong understanding of CMC development and regulatory affairs.Coordinate inputs across departments and external stakeholdersManage risk proactively using scientific and operational insightPrepare and facilitate technical project meetingsKey Skills:Project management experience in biotech...


  • Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

    About the CompanyBlack Swans Exist is a biotech company focused on developing innovative biologics and combination drug-device products for women's reproductive health. We're committed to improving women's lives through our groundbreaking therapies.The RoleWe're seeking a seasoned Director of Regulatory Affairs to lead our global regulatory strategies. As a...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleGenmab's clinical pipeline is growing rapidly, and we are seeking a highly skilled Senior Associate CMC to join our stability team in Denmark. This position will be responsible for ensuring that stability activities are conducted in compliance with project timelines and regulatory requirements.Partner with Genmab QC, CMC PMs, QA, and CMOs to...