Global Regulatory Lead

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 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...

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...

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...

Job SummaryThis role is an excellent opportunity for a seasoned Regulatory Affairs professional to lead regulatory projects both locally and globally. The ideal candidate will have a strong background in regulatory compliance, excellent communication skills, and the ability to work effectively in a fast-paced environment.The selected candidate will be...

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...

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...

Unlock the Potential of Regulatory AffairsGenmab A/S is seeking a highly experienced and skilled Global Regulatory Expert to join its team. As a key member of the Global Regulatory Affairs organization, you will play a crucial role in shaping the company's regulatory strategies and ensuring the successful execution of global submissions.About the RoleThe...

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...

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...

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...

Join us at Coinify ApS, a leading global virtual currency platform, and become a part of our dynamic AML compliance team. We are seeking a Senior AML Officer to ensure regulatory compliance, manage AML/CFT risks, and lead key compliance projects.With a presence in over 150+ markets, Coinify empowers businesses and individuals to engage with financial...

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 GenmabGenmab is an international biotechnology company committed to improving the lives of patients through innovative antibody therapeutics. We leverage translational research and data sciences to develop next-generation antibody technology platforms, including bispecific T-cell engagers, immune checkpoint modulators, effector function enhanced...

Job Description:The Senior Regulatory Lead EU/ROW will be responsible for ensuring regulatory oversight and progress of clinical trial submissions in the EU/ROW region. This role will represent RA in the Clinical Trial Teams and work closely with CROs and internal stakeholders to ensure compliance with regulatory requirements.Key Responsibilities:Represent...

At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...

We are looking for a Regulatory Compliance Lead to join our team at Macure Pharma. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines. Your expertise in eCTD publishing and regulatory submission workflows will be instrumental in shaping our digital regulatory...

About UsWe are a fast-growing, dynamic company dedicated to transforming the lives of people with cancer and other serious diseases through Knock-Your-Socks-Off (KYSO) antibody medicines. Our core purpose guides our unstoppable team to strive towards improving patient lives through innovative and differentiated antibody therapeutics.The Role and DepartmentIn...

Role OverviewThe VP of Public Policy and Regulatory Affairs will lead the development of AstroPay's global regulatory strategy, ensuring compliance with international financial regulations and alignment with business goals. This role will oversee the company's engagement with regulatory bodies, shape public policy initiatives, and ensure seamless...

At Genmab, we're committed to transforming the lives of patients through innovative cancer treatments. Our Global Regulatory Affairs organization is seeking a highly motivated and experienced individual to join our team as an Associate Director, Global Regulatory Affairs Project Lead.This role will involve representing RA in Clinical Trial Teams and working...