Global Regulatory Expert

Mito Consulting is committed to providing exceptional service to our clients in the BioPharma industry.Regulatory Compliance ExpertWe are seeking a highly skilled Regulatory Compliance Expert to join our team. The ideal candidate will have a strong background in regulatory compliance and quality control, with experience working in the BioPharma industry.The...

We are looking for a highly skilled Global Regulatory Lead to join our Regulatory Affairs CMC team at Genmab A/S. As a key member of our team, you will be responsible for providing strategic regulatory guidance and support for the development and commercialization of our biologic products.The ideal candidate will have a strong understanding of global...

This is an excellent opportunity for someone who is passionate about quality and regulatory affairs to join a leading company in the medical device industry. As a QA/RA specialist, you will be responsible for ensuring compliance with regulatory requirements, including MDR and ISO 13485, and will have the opportunity to work on a wide range of projects, from...

About the RoleIn this critical position, you will play a key role in driving regulatory strategy and ensuring compliance with global and local regulations. You will collaborate closely with internal stakeholders, including Global Regulatory Affairs, Supply Chain, QA, Market Access, Marketing, and Medical.The responsibilities of this role include leading...

Oresund Pharma ApS is a dynamic and ambitious company seeking a talented Global Regulatory Manager to join our Regulatory department.In this role, you will be responsible for ensuring that our products comply with regulatory requirements and commercial demands worldwide. This includes managing regulatory submissions, establishing relationships with...

Regulatory Director Job DescriptionTbwa Chiat/Day Inc is seeking a highly experienced and skilled Regulatory Director to join our team. This key regional leader will play a crucial role in shaping our regulatory strategy and compliance framework, ensuring alignment with global objectives while addressing local market nuances.The ideal candidate will have...

We are looking for a Senior Regulatory Expert to join our team at Macure Pharma. As a key member of our Regulatory Affairs department, you will be responsible for implementing and optimizing our new Submission Publishing Tool. Your expertise in eCTD publishing and regulatory submission workflows will be instrumental in shaping our digital regulatory...

Job Description:We are looking for a Regulatory Affairs Expert for Medical Devices to join our Clinical and Regulatory team. The ideal candidate will have a strong background in regulatory affairs, with experience in medical devices. You will be responsible for ensuring that our medical devices meet the highest regulatory standards and that we comply with...

About the RoleTbwa Chiat/Day Inc is seeking a highly experienced and skilled Regulatory Director to join our team. This key regional leader will play a crucial role in shaping our regulatory strategy and compliance framework, ensuring alignment with global objectives while addressing local market nuances.The ideal candidate will have deep legal and...

Get AI-powered advice on this job and more exclusive features. Global Talent Management Specialist - KEVIN.MURPHY Who We Are: At KEVIN.MURPHY , we are committed to both the environment and the diverse communities we serve. From the very beginning, we've focused on creating products that are kind to hair and the planet, with sustainability and ethical...

About the RoleWe are seeking an experienced Global Regulatory Affairs Project Lead to join our team in Copenhagen, Denmark. In this role, you will be responsible for leading the development and execution of the EU/ROW regulatory strategy for assigned projects.Key ResponsibilitiesAct as EU/ROW regulatory lead and EMA contact person for assigned...

Job Overview:The Senior Director of Global Regulatory Affairs will lead Tbwa Chiat/Day Inc's global regulatory strategy, ensuring compliance with international financial regulations and alignment with business objectives. This role involves overseeing the company's engagement with regulatory bodies, shaping public policy initiatives, and ensuring seamless...

We are looking for an exceptional individual to join our team as an Associate Director, Global Regulatory Affairs Project Lead. As a key member of our Global Regulatory Affairs organization, you will play a critical role in ensuring regulatory compliance and oversight for our clinical trials.In this role, you will represent RA in Clinical Trial Teams and...

About the RoleAt Genmab, we're pushing the boundaries of antibody therapies to transform lives. As a Director/Associate Director, Global Regulatory Affairs, you'll play a crucial role in shaping our regulatory strategy for biologics.This exciting opportunity requires a seasoned professional with expertise in CMC regulatory affairs, strategic thinking, and...

Oresund Pharma is seeking a Regulatory Affairs Manager to lead our product registration efforts globally. As a key member of our Regulatory department, you will ensure the successful delivery of regulatory plans aligned with business priorities.Key Responsibilities:Oversee the regulatory lifecycle management of our product portfolio.Ensure product compliance...

Benefits and OpportunitiesAs a member of our team, you'll enjoy a range of benefits and opportunities that support your growth and well-being.About the Job:Contribute to the development and execution of global regulatory CMC strategies for biologics.Collaborate with cross-functional peers to facilitate and optimize product development.Stay up-to-date on EU,...

We're seeking a talented and motivated Senior Director to lead our Regulatory Affairs function.In this role, you'll be responsible for developing global regulatory strategies for our portfolio of development pipeline candidate drugs and marketed products.You'll provide strategic input and ensure operational execution of global submission activities,...

Key ResponsibilitiesOversee and direct an awesome team of highly engaged associates and focus on continuous development of the team.Drive process improvements for RA owned processes and procedures.Implement systems and tools that support the Regulatory Affairs organization towards a more efficient way of working.RequirementsMinimum bachelor's degree in a...

About the JobWe are seeking a seasoned Regulatory Affairs professional to join our Global Regulatory Affairs team. As a Senior Director, you will be responsible for the development and implementation of EU/ROW regulatory strategies for Genmab's programs across all stages of development. You will work closely with cross-functional teams to ensure an optimal...

Key ResponsibilitiesProvide regulatory input and technical guidance on local regulatory requirements to product development teams.Assess the acceptability of quality, preclinical, and clinical documentation for submission filing to comply with applicable local Health Authority requirements.Prepare and submit regulatory submissions according to applicable...