Regulatory Affairs Expert

2 days ago


Malmo, Skåne, Sweden Capgemini Full time
Job Description

We are seeking a highly skilled Senior Regulator Affairs Consultant to join our team in Malmö.

In this role, you will work closely with major pharmaceutical clients to deliver patient-focused, compliant, and efficient solutions. Your expertise will be crucial in navigating complex CMC regulatory requirements, ensuring that pharmaceutical development meets stringent quality standards from initial research through to commercial manufacturing and product lifecycle management.

Required Skills and Qualifications:
  • Degree within Biotechnology, Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biomedical Engineering or closely related field
  • Solid experience within regulatory affairs for the pharmaceutical industry
  • Comprehensive understanding in Chemistry, Manufacturing, and Controls (CMC) within pharmaceutical development
  • Knowledgeable in preparing comprehensive technical documentation, specifically Common Technical Document (CTD) submissions
  • Comprehensive understanding of EU pharmaceutical regulations, encompassing product registration, manufacturing processes, and compliance with EMA guidelines and GxP quality standards
  • Fluent in spoken and written Swedish and English
Meritorious Skills:
  • Comprehensive understanding of Certification of European Pharmacopoeia (CEP) standards and processes
  • Knowledge of US pharmaceutical regulatory frameworks, including FDA guidelines and compliance requirements
  • Experience within project management


  • Malmo, Skåne, Sweden Magle Chemoswed AB Full time

    Magle Group is growing and we are looking Regulatory Affairs Specialist who is looking for a new challenge and who wants to be part of a small but dynamic regulatory team. Magle Group is supporting other Life Science Companies by providing CDMO services as well developing and manufacturing our own products with DSM technology. This role will focus on...


  • Malmo, Skåne, Sweden Magle Group Full time

    At Magle Group, we believe in making an impact by improving lives for patients worldwide. We are seeking a highly skilled Regulatory Affairs Specialist to join our team and support our medical devices business.This role will involve preparing and submitting regulatory documentation required for approval and registration in various international markets, as...


  • Malmo, Skåne, Sweden Magle Chemoswed Full time

    Job Description:Magle Chemoswed is a leading provider of Contract Development and Manufacturing Organization (CDMO) services to the Life Science industry. We are seeking a highly skilled Regulatory Affairs Specialist to join our dynamic regulatory team.In this role, you will be responsible for ensuring compliance with international regulatory standards and...


  • Malmo, Skåne, Sweden Magle Chemoswed AB Full time

    Magle Chemoswed AB is expanding its regulatory team and seeking a skilled Regulatory Affairs Specialist to support our medical devices business. As a key member of the team, you will be responsible for ensuring compliance with regulatory standards and guidelines applicable in our active markets.Responsibilities:Develop and implement regulatory strategies to...


  • Malmo, Skåne, Sweden Magle Chemoswed Full time

    Key Responsibilities:The Regulatory Affairs Specialist will be responsible for ensuring compliance with international regulatory standards and guidelines applicable in our active markets. The key responsibilities of this position include:Preparing and submitting regulatory documentation required for the approval and registration of new and existing products...


  • Malmo, Skåne, Sweden Magle Group Full time

    Magle Group is a dynamic and innovative company that provides CDMO services and develops and manufactures products with DSM technology. We are seeking a highly skilled Regulatory Affairs Specialist to join our small but dynamic regulatory team. This role will focus on supporting our medical devices business and ensuring compliance with all regulatory...


  • Malmo, Skåne, Sweden Magle Group - Malmö Full time

    Magle Group is a dynamic company located in Malmö that supports Life Science Companies by providing CDMO services and developing and manufacturing our own products with DSM technology.We are looking for a Regulatory Affairs Specialist who will focus on supporting our medical devices business and ensuring compliance with all regulatory standards and...


  • Malmo, Skåne, Sweden Capgemini Full time

    Job OverviewCapgemini Engineering seeks a talented Senior Regulator Affairs Consultant to join our team in Malmö. In this role, you will have the opportunity to work with major pharmaceutical clients, driving business growth and delivering high-quality solutions.You will be responsible for developing and implementing regulatory strategies, ensuring...


  • Malmo, Skåne, Sweden Magle Group Full time

    Magle Group is a dynamic and innovative company that provides CDMO services and develops and manufactures products with DSM technology. We are seeking a talented Regulatory Affairs Specialist to join our team and support our medical devices business.This role will involve preparing and submitting regulatory documentation required for approval and...


  • Malmo, Skåne, Sweden Magle Chemoswed AB Full time

    Magle Group is a dynamic and growing company in the Life Science industry, providing CDMO services and developing products with DSM technology. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with regulatory standards and guidelines applicable in our active markets.Key Responsibilities:Prepare and submit regulatory...


  • Malmo, Skåne, Sweden Magle Group Full time

    We are Magle Group, a value-driven organization that has an interesting journey ahead. We are looking for a talented Regulatory Affairs Specialist to support our medical devices business and ensure compliance with all regulatory standards and guidelines applicable in our active markets.This role will be responsible for preparing and submitting regulatory...


  • Malmo, Skåne, Sweden Capgemini Full time

    About the RoleThis position is ideal for a professional with exceptional skills in coordinating and advising on pharmaceutical regulatory affairs. As a Senior Regulator Affairs Consultant, you will be working with diverse clients, providing strategic guidance and support to achieve their quality and regulatory objectives.The role involves collaborating with...


  • Malmo, Skåne, Sweden Magle Chemoswed Full time

    Job Overview:We are seeking a skilled Regulatory Affairs Specialist to join our regulatory team. In this role, you will be responsible for ensuring compliance with international regulatory standards and guidelines applicable in our active markets.Your key responsibilities will include:Preparing and submitting regulatory documentation required for the...


  • Malmo, Skåne, Sweden Capgemini Full time

    Senior Regulator Affairs Consultant Job SummaryThis is an exciting opportunity to join Capgemini Engineering as a Senior Regulator Affairs Consultant in Malmö. In this role, you will have the chance to work with diverse clients, providing strategic guidance and support to achieve their quality and regulatory objectives.You will be responsible for developing...


  • Malmo, Skåne, Sweden Leo Pharma Inc. Full time

    Join Our Team of Medical ExpertsWe're seeking a highly skilled Nordic Medical Affairs Lead to join our team at LEO Pharma Inc. This is an exciting opportunity to contribute to our mission to become leaders in medical dermatology worldwide.About the RoleYou will be responsible for overseeing operations in the Nordic region, including Finland, Norway, Denmark,...


  • Malmo, Skåne, Sweden Magle Group - Malmö Full time

    The successful candidate will have a strong understanding of international regulatory guidelines and standards such as FDA, CE Marking, NBOG, ISO 13485, MDR, etc., and will be able to apply this knowledge to prepare successful regulatory submissions.You will work closely with cross-functional teams to ensure compliance with global regulatory requirements and...


  • Malmo, Skåne, Sweden Randstad Full time

    We are a dynamic and rapidly growing Pharma company committed to developing innovative medicinal products that improve patient health. We are seeking a QA Expert to join our team in the Malmö/Lund area.In this role, you will be responsible for:Ensuring compliance with regulatory requirements and industry standardsDeveloping and implementing quality...


  • Malmo, Skåne, Sweden Magle Group - Malmö Full time

    As a key member of our regulatory team, you will be responsible for preparing and submitting regulatory documentation required for the approval and registration of new and existing products in various international markets.You will stay updated on regulatory procedures and changes in the regulatory climate to ensure compliance and advise the company on...


  • Malmo, Skåne, Sweden Magle Chemoswed Full time

    Responsibilities:As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with international regulatory standards and guidelines applicable in our active markets. Your key responsibilities will include:Preparing and submitting regulatory documentation required for the approval and registration of new and existing products in...


  • Malmo, Skåne, Sweden Capgemini Full time

    We are seeking a Regulated Packaging Expert to join our team at Capgemini Engineering. As a key member of our packaging development team, you will be responsible for developing and implementing packaging solutions that meet stringent standards for medical and pharmaceutical industries. Your expertise in regulatory compliance, quality management systems, and...