Global Regulatory Project Manager (all genders)

Posted 04 Aug 2022

Darmstadt, Hessen - Germany

Req Id 244905

Details

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


Your role:

An exciting new opportunity has arisen to join our company as Regulatory Project Manager in Healthcare. As a key partner to the Global Regulatory Lead, you ensure with the Global Regulatory Sub team that the regulatory strategy will be implemented as planned. You build project plans for submissions to Health Authorities worldwide with a focus on initial clinical trial and/or marketing authorization applications and major variations. You set-up kick-off meetings and regular Submission Task Force meetings for submission preparation with relevant partners. In close interaction with the Regulatory Lead and cross-functional teams, you assess and resolve any issues impacting timelines and perform spot checks on published outputs. In addition, you will be responsible for providing transparency on global regulatory budget demands and tracking of actual spending (if applicable). You are encouraged to contribute to the improvement of planning capabilities within Regulatory and to increase efficiency in internal processes. You manage and improve tools and templates for project management that ensure compliance with regulatory strategy, regulatory project timelines and Health Authority requirements. You represent Regulatory Operations in Global Regulatory Sub team and Global Project Teams.

 

Who you are:

  • Degree in a Life Science and/or related field and/or 6+ years’ experience in a Regulatory Operations environment

  • Solid experience in project management and technology solutions

  • Excellent spoken and written English, and a second language would be an asset.

  • In-depth knowledge of regulatory applications needed to support the regulatory function according to the role

  • Standout colleague with ability to work with multidisciplinary teams within a matrix and in an international environment

  • Project Management skills and/or certification are a plus


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html

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