Senior Associate, Global Submission Management

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 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...

Job DescriptionThe Senior Associate, Clinical Trial Submission Management, will help ensure the technical compliance of our Clinical Trial submissions via the smooth compliant flow of information between all functional areas, internal and external to GRAAS, local offices, external partners and regulatory authorities. This vital role is assigned to one or...

Job DescriptionThe Senior Associate, Data Management, will help drive key business operation initiatives within Veeva RIM Vault, ensuring alignment with global regulatory requirements such as IDMP, EU CTR, and other emerging regulations.You will lead efforts to implement and support regulatory processes, ensuring compliance, efficiency, and the delivery of...

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...

Job DescriptionMajor accountabilities:- Is responsible for implementing regulatory strategy and managing operational activities for assigned medium regions.- Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic...

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 DescriptionAudit & Assurance: Senior Associate/Senior - US GAAP, UK GAAP, IFRS, FRS 102Our Audit & Assurance team is one of the growing teams in our office. As part of our team, you will provide our clients' your valuable inputs by using your skills and experience to give companies, investors, and regulators confidence in the validity of financial...

Career Category Human Resources Senior Associate Global Mobility - GCF 4 Location Hyderabad India At Amgen every challenge is an opportunity And every opportunity brings the potential to change lives Our shared mission to serve patients has driven our status as one of the world s preeminent biotechnology companies reaching over millions of...