Regulatory Operations Associate

Vor 3 Tagen


München, Deutschland Daiichi Sankyo Europe Vollzeit

Under supervision, provide regulatory operational support for European submission projects for prospective and authorize products in a timely manner. Ensure regulatory operations compliance and may act as a technical specialist in a particular area. In this role, you will be part of a highly competent team resided in Munich and in Basking Ridge/US.

**Roles and Responsibilities**:

- Preparation of the assigned eCTD submissions in collaboration with the EU Regulatory Affairs and Regulatory Operation counterparts in the US
- Responsible for the control of Daiichi Sankyo document standards are adhered
- Ensuring on-time delivery of high quality, compliant and valid eCTD submissions for the different countries
- Manage the dispatch of the submissions via diverse electronic submission channels (e.g. CESP, EMA Gateway)
- Participating in special projects (e.g. developing processes within the team’s area of responsibility)

**Personal Skills and Professional Experience**:

- Bachelor’s degree in natural science or PTA education
- 2-3 years of experience in the regulatory environment
- Hands-on experience with the eCTD compilation and publishing
- Proven ability to work with a document management system and an electronic publishing tool
- Used to work towards deadlines and able to prioritize
- Collaborative and service-oriented mindset
- Strong working knowledge of Microsoft Office
- Written and verbal communication skills in English, German is a plus

**Why work with us?**:



  • München, Deutschland Cambridge Associates LLC Vollzeit

    **Firm Overview** We are a leading global investment firm and aim to help endowments & foundations, pension plans, and high net worth private clients implement and manage custom investment portfolios that generate outperformance and enable them to maximize their impact on the world. Working alongside its early clients, Cambridge Associates pioneered the...


  • München, Deutschland Lime Gmbh Vollzeit

    We are looking for a data-driven, hands-on, entrepreneurial minded individual to join our Munich Operations team. As an Operations Associate, you will enhance our fleet, coordinate our teams in the warehouse and in the field, and be the local eyes and ears on the ground to understand the local needs of our riders. You will tackle challenges along our...


  • München, Deutschland Veranex, Inc. Vollzeit

    Veranex is the leading service provider for medtech companies. Our global team of experts help clients anticipate challenges and find solutions throughout the development and commercial lifecycle. Together, we accelerate new technologies to market and improve patient outcomes. **About This Role**: We are seeking an experienced Vice President or Senior Vice...


  • München, Deutschland Veranex, Inc. Vollzeit

    Veranex is the leading service provider for medtech companies. Our global team of experts help clients anticipate challenges and find solutions throughout the development and commercial lifecycle. Together, we accelerate new technologies to market and improve patient outcomes. **About This Role**: We are seeking an experienced Vice President of Regulatory &...


  • München, Deutschland Organon Vollzeit

    Organon is looking for a **Supply Chain Operations Associate Specialist** who will be joining the Central North Europe Cluster (CNE) at Organon and will be mainly supporting distribution and logistics activities for the cluster markets. You will be reporting to the Supply Chain Operations Manager for Germany, Austria and the Netherlands. This is a remote...


  • München, Deutschland Moxa Vollzeit

    **Description** We are seeking **a passionate Sales Operations Associate (M/F/d)** to join our great team and enhance our sales processes while ensuring exceptional customer experiences across our key markets! The position is currently offered as a **fixed-term employment contract** to cover for a colleague on maternity leave, with the option for future...

  • Community Associate

    vor 3 Monaten


    80331 München, Deutschland Mindspace Vollzeit

    **About Mindspace** Founded in 2014, Mindspace is a leading flexible workspace provider with an expanding footprint in Europe, Israel and the US. Our design-led office spaces and on-demand offerings such as meeting rooms, event spaces and daily offices provide the ideal solution for enterprise companies, startups, small businesses and entrepreneurs adapting...


  • 80335 München, Deutschland PIMCO Vollzeit

    PIMCO is a global leader in active fixed income with deep expertise across public and private markets. We invest our clients’ capital across a range of fixed income and credit opportunities, leveraging our decades of experience navigating complex debt markets. Our flexible capital base and deep relationships with issuers have helped us become one of the...

  • ERP Associate

    vor 3 Wochen


    München, Deutschland LivaNova Vollzeit

    Join us today and make a difference in people's lives! ERP Associate (M/F/d) If necessary, he/she shall address the issues to the relevant IT department, either locally to our on-site support team or to another part of our IT organization. General Responsibilities - Ensure the service provider contact points have the correct remote access to our...

  • Founder's Associate

    vor 2 Wochen


    München, Deutschland comstruct ICT Vollzeit

    **Founder’s Associate** FULL-TIME HYBRID (50% MUNICH / 50% REMOTE) **YOUR MISSION** As a **Founder’s Associate (M/F/x)**, you'll work directly with our CEO (Henric Meinhardt) on key areas like finance, recruiting, fundraising, and operations. You'll start in a hybrid setup from our Munich office and play an active role in shaping the company's...

  • Consulting Associate

    vor 3 Monaten


    München, Deutschland Charles River Associates Vollzeit

    **About Charles River Associates** **Charles River Associates** is a leading global consulting firm that offers economic, financial, and strategic expertise to major law firms, corporations, and governments around the world. For nearly 60 years, CRA experts have combined rigorous cutting-edge research, state-of-the-art methodology, and proven experience to...

  • Consulting Associate

    vor 3 Monaten


    München, Deutschland bioStrategies Group Vollzeit

    **About Charles River Associates** **Charles River Associates** is a leading global consulting firm that offers economic, financial, and strategic expertise to major law firms, corporations, and governments around the world. For nearly 60 years, CRA experts have combined rigorous cutting-edge research, state-of-the-art methodology, and proven experience to...

  • Founder's Associate

    vor 1 Monat


    81671 München, Deutschland Cartken Vollzeit

    **Who we are**: Cartken is a startup at the forefront of autonomous robotics and last-mile delivery. Our team has more than a century of combined experience solving some of the toughest challenges in autonomous vehicles, robotics, and operations at Google, Amazon, Apple, and Facebook. We have robots operating around the world providing reliable and...


  • 81379 München, Deutschland ConMoto Consulting Group GmbH Vollzeit

    **Stellenbeschreibung** **(Senior) Associate Procurement **(m/w/d)**: in **Düsseldorf, Berlin, Frankfurt, Hamburg, Köln, München** oder **Wien**. ConMoto Strategie und Realisierung GmbH ist die umsetzungsstarke Managementberatung und arbeitet mit Erfolg seit mehr als 30 Jahren weltweit für namhafte Unternehmen. 2023 haben wir uns mit Horn & Company...


  • München, Deutschland Contentsquare Vollzeit

    Contentsquare is a global digital analytics company empowering the brands you interact with every day to build better online experiences for all. Since our founding in France in 2012, we have grown to be a truly global and distributed team - known as the CSquad - representing more than 70 nationalities across the world. In 2022, we raised $600M in Series F...


  • München, Deutschland Avelios Medical GmbH Vollzeit

    **About this role**: Our mission at Avelios is to build the leading software platform for the data-driven digitization of hospitals and patient care. To do so, we have built a modular software platform that digitizes and optimizes workflows in hospitals with cutting-edge technology in a user-friendly way. With our software, we enable hospitals and doctors to...


  • 80539 München, Deutschland NetJets Europe Vollzeit

    **Purpose of Position**: Support the sales cycle from start to finish by managing the sales operation. **Tasks and Responsibilities**: - Acts as the internal knowledge expert for NetJets program information, lead capture, CRM database, and guides Sales Management in correctly identifying activity within the CRM system; - Create and execute proposals for...


  • 80336 München, Deutschland CoCrafter (YC W24) Vollzeit

    We are CoCrafter (YC W24), a Munich-based start-up founded in 2023 with a mission to revolutionize collaboration processes in construction. The construction industry is the backbone of the European economy but has been largely overlooked by digitization efforts. The result: inefficient processes and untapped potential. Subcontracting is one of the most...

  • Associate Director

    vor 3 Monaten


    München, Deutschland BAXTER Vollzeit

    **This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Founders Associate

    vor 3 Monaten


    80992 München, Deutschland comstruct ICT GmbH Vollzeit

    **YOUR MISSION**: comstruct is a fast-growing construction startup with a fundraising round coming up. As a Founders Associate (M/F/x), you'll work directly with the founders on key areas like finance, recruiting, fundraising, and operations. You'll start in a hybrid setup from our Munich office and play an active role in shaping the company's growth. - Ops:...