Global Submission Management Professional

Career Category RegulatoryThe Senior Associate Global Submission Management Americas will help ensure the smooth compliant flow of information between all functional areas internal and external to GRAAS including local offices external partners and regulatory authorities within the North American context This role leads the creation of regulatory...

Job DescriptionRoles & Responsibilities:- Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans.- Participation in information system and software update projects as well as ongoing system validations- Serve as point of contact between Amgen's functional contributors and external...

About the RoleAs a Clinical Trial Submission Management Specialist, you will be responsible for ensuring Clinical Trial Application approvals in the EU throughout the whole study lifecycle. This involves working closely with cross-functional teams to ensure compliance with EU regulations and guidelines.Key responsibilities include preparing submission...

Job DescriptionLead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans.- Participation in information system and software update projects as well as ongoing system validations.- Serve as point of contact between Amgen's functional contributors and external partners, to ensure smooth...

Key AccountabilitiesAs a seasoned regulatory professional, your primary responsibilities will involve developing and implementing global regulatory strategies to ensure timely submissions and approvals. You will collaborate closely with regional teams to align on regulatory approaches and facilitate the submission of dossiers worldwide.Main...

Job DescriptionRoles & Responsibilities:- Be assigned to one or more Amgen products under development to ensure Clinical Trial Application approvals in the EU throughout the whole study lifecycle. As technical experts in the EMA Clinical Trial Information System (CTIS), ensure compliance with the EU Clinical Trials Regulation (EU CTR) for every Clinical...

Job Title: Regulatory Submission SpecialistWe are seeking a highly skilled Regulatory Submission Specialist to join our team. The ideal candidate will have extensive knowledge of EU Clinical Trial Applications and experience in regulatory document management.Key Responsibilities:Ensure technical compliance of clinical trial submissions via smooth information...

International Regulatory Lead Job DescriptionWe are seeking a highly skilled and experienced International Regulatory Lead to join our team. As an International Regulatory Lead, you will be responsible for advising global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and...

Senior Manager, Regulatory Affairs and ComplianceJob Description:The role of Senior Manager, Regulatory Affairs and Compliance involves leading global regulatory strategy with a focus on innovation, ensuring business benefit balanced with regulatory compliance. This includes leading and implementing all global CMC submission activities for assigned...

As a key player in the regulatory submission process, you will have the opportunity to work closely with cross-functional teams to ensure compliance with global labeling requirements.Job Description:Develop and implement effective labeling strategies, collaborating with stakeholders across multiple regions and functions. Utilize your analytical skills to...