2 Submissions Jobs

This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation, and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & 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 partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective. Contribute to the development of the strategy for communicating with global health authorities. Initiate, lead, and manage process development and improvement. Participation in information system and software update projects as well as ongoing system validations. Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams. Working knowledge of worldwide regulatory submissions in electronic Common Technical Document (eCTD) format, NeeS, and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance, and overall management of Global/Submission Content Plans, reports, and dashboards. Advanced knowledge of Global, International, and Emerging Markets Marketing Application submission requirements, country specifications, and software used. Advanced knowledge of eCTD, eCTD Specifications, and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred). Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM. Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications. Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master's degree and 3-4 years of directly related experience OR Bachelor's degree and 4-6 years of directly related experience OR Associate's degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for EU, JAPAC, GCC, ZA.

Asset & Wealth Management Bringing together traditional and alternative investments, we provide clients around the world with a dedicated partnership and focus on long-term performance. As the firm's primary investment area, we provide investment and advisory services for some of the world's leading pension plans, sovereign wealth funds, insurance companies, endowments, foundations, financial advisors and individuals, for which we oversee more than $2 trillion in assets under supervision. Working in a culture that values integrity and transparency, you will be part of a diverse team that is passionate about our craft, our clients, and building sustainable success. We are: Investors , spanning traditional and alternative markets offering products and services Advisors , understanding our clients priorities and poised to help provide investment advice and strategies that make sense for their portfolios Thought Leaders , providing timely insights across macro and secular themes to help inform our clients investment decisions Innovators , using our suite of digital solutions to help our clients address complex challenges and meet their financial goals AlternativesCapital Formation (ACF) is aglobal team with100+ alternative investment product specialists acrossmore than 10offices, includingNew York,London, Hong Kong,andBengaluru. The team isresponsible for GS Alternativesfundraising acrossprivate equity, private credit, real estate, infrastructure, growth equity, sustainability, secondaries, hedge funds, andliquid alternatives strategies. ACF is seeking an ACF EMEA compliance coordinator at the associate level to facilitate compliance approvals for the ACF and be the centre of excellence for EMEA compliance submissions. The individual will have the opportunity to collaborate with various product teams within ACF as well as Commercial Strategy team which focuses on client & fundraising strategy, product prioritization, and campaign design across the alternatives investment platform, and interact with MDs gaining valuable exposure and comprehensive understanding of our alternatives offerings. Responsibilities Support global ACF team in preparing and submitting to compliance systems marketing materials that are in compliance with global regulations in particular EMEA regulatory requirements Coordinate with internal teams to gather necessary information for efficient compliance submissions Closely work with Managing Directors in EMEA for review & sign-off of client meeting materials Maintain detailed records of all submissions Help ensure compliance with all relevant EMEA regulations, standards and guidelines Be the centre of excellence for ACF compliance submissions Qualifications Minimum of 2-5 years of prior work experience Highly organized with attention to detail and excellent follow-through Self-starter who takes pride and ownership in their work Ability to work in a fast-paced environment and think clearly under pressure Flexibility to handle multiple tasks and work well under pressure