Associate Director Regulatory Affairs CMC

1 maand geleden

Utrecht, Nederland Merus N.V. Voltijd

Join our mission to close in on cancer. The Team

As a member of our CMC (Regulatory Affairs) team, you will play an important role in managing, writing, preparation, and review of RA-CMC regulatory filings for submissions of Merus’ product candidates in compliance with the applicable regulatory and quality requirements. You will also provide biopharmaceutical CMC-content related regulatory advice to the rest of the CMC team. The Role

As Regulatory Affairs CMC Officer, your main tasks and responsibilities are the following:

Preparation and co-review of CMC sections of regulatory filings Managing Regulatory Affairs CMC-related projects of Merus’ product candidates both internally (with Merus colleagues) and externally (third parties) Ensuring that CMC regulatory filings are in compliance with internal procedures, regulatory guidelines, and according to GMP, GLP, and/or GDP, where applicable Provide regulatory advice on CMC technical and quality matters to the rest of the CMC team, such as manufacturing process development, specifications, in process controls, and change control management

Managing the communication and follow-up with Competent Authorities on CMC regulatory related feedback received. Your Profile

We are looking for a Regulatory Affairs CMC Manager with the following knowledge and expertise:

You hold a Master’s degree in a relevant biomedical field and have at least 3 years of relevant working experience within the (bio)pharmaceutical industry or other relevant regulatory experience You have a good understanding of Regulatory Affairs (EU/US/ROW) You have a good understanding of various quality systems such as GMP, GLP, and GDP You are a team player focused on results You have an analytical mindset and attention to detail You are known for your organization skills and drive to continuously improve your work You communicate well in English, both verbally and in writing Why Merus?

We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll experience a steep learning curve from your very first day in the job. And you’ll get to interact with a great international team of people who love what they do To top it all, we offer a competitive salary, flexible working hours, an excellent pension scheme, a company bonus, and 30 days’ annual leave (based on a full-time position). Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.

  • Senior Director, Regulatory Affairs Strategy-EU/RoW

    2 dagen geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    Job SummaryWe are seeking a highly experienced Senior Director to lead our Regulatory Affairs team in the EU/ROW region. As a key member of our Global Regulatory Affairs organization, you will be responsible for developing and implementing regulatory strategies for our programs across all stages of development.Key ResponsibilitiesDevelop and implement global...

  • Senior Director, Regulatory Affairs Strategy-EU/RoW

    6 dagen geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    Job Title: Senior Director, Regulatory Affairs Strategy-EU/RoWGenmab is seeking a highly experienced Senior Director to lead our Regulatory Affairs Strategy team in the EU/ROW region. As a key member of our Global Regulatory Affairs organization, you will be responsible for developing and implementing regulatory strategies for our programs across all stages...

  • Senior Director, Regulatory Affairs Strategy-EU/RoW

    2 weken geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About the RoleWe are seeking a highly experienced Senior Director to lead our Global Regulatory Affairs organization in the EU/ROW region. As a key member of our team, you will be responsible for developing and implementing a comprehensive regulatory strategy for our programs across all stages of development.Key ResponsibilitiesDevelop and execute global...

  • Senior Director, Regulatory Affairs Strategy-EU/RoW

    4 maanden geleden

    Utrecht, Nederland Genmab Voltijd

    The Role & DepartmentAs a Senior Director, you will join our Global Regulatory Affairs organization. In this capacity, you will assume responsibility for the EU/ROW regulatory strategy for an assigned program and will manage a group of Regulatory Strategists with EU/ROW responsibilities for our programs across all stages of development. The chosen candidate...

  • Senior Director, Regulatory Affairs Strategy-EU/RoW

    2 dagen geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    Job SummaryWe are seeking a highly experienced Senior Director to lead our Regulatory Affairs team in the EU/ROW region. As a key member of our Global Regulatory Affairs organization, you will be responsible for developing and implementing regulatory strategies for our programs across all stages of development.Key ResponsibilitiesDevelop and implement EU/ROW...

  • Senior Director, Regulatory Affairs Strategy-EU/RoW

    7 dagen geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    Job SummaryWe are seeking a highly experienced Senior Director to lead our EU/ROW Regulatory Affairs team. As a key member of our Global Regulatory Affairs organization, you will be responsible for developing and implementing regulatory strategies for our programs across all stages of development.Key ResponsibilitiesDevelop and implement EU/ROW regulatory...

  • Senior Director, Regulatory Affairs Strategy-EU/RoW

    4 dagen geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    Job SummaryWe are seeking a highly experienced Senior Director to lead our Regulatory Affairs organization in the EU/ROW region. As a key member of our global team, you will be responsible for developing and implementing regulatory strategies for our programs across all stages of development.Key ResponsibilitiesDevelop and implement EU/ROW regulatory...

  • Medical Affairs Director, Oncology

    2 weken geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About the RoleThe Director, Global Medical Affairs Strategy will play a critical role in driving the development and execution of the Global Medical Affairs strategic and tactical plans for the asset(s) for the primary indication as well as new indications to expand into as part of the asset life cycle management.Key ResponsibilitiesLead Annual Medical...

  • Regulatory Affairs Specialist

    3 maanden geleden

    Utrecht, Nederland Mediq Voltijd

    What are you going to do? Your position as a Regulatory Affairs Specialist is in our Quality Management team where we always have various projects on the agenda. Regulatory affairs for medical devices is a wide area with a wide range of expertise in clinical and in technical aspects. Your main responsibilities consists of: Collecting, registering,...

  • Global Corporate Affairs Associate Director, Alzheimer's Disease Expert

    2 weken geleden

    Utrecht, Utrecht, Nederland Lilly Voltijd

    Job Title: Global Corporate Affairs Associate Director, Alzheimer's DiseaseWe're seeking a highly skilled and experienced professional to join our team as a Global Corporate Affairs Associate Director, Alzheimer's Disease. This role will play a crucial part in supporting the development and implementation of international strategies to improve the detection,...

  • Director, Global Medical Affairs Strategy Lead

    2 weken geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About the RoleThe Director, Global Medical Affairs Strategy will play a critical role in driving the development and execution of the Global Medical Affairs strategic and tactical plans for the asset(s) for the primary indication as well as new indications to expand into as part of the asset life cycle management.Key ResponsibilitiesLead Annual Medical...

  • Global Corporate Affairs Associate Director, Alzheimer’s disease

    3 maanden geleden

    Utrecht, Nederland Lilly Voltijd

    We’re looking for people who are determined to make life better for people around the world. The Associate Director of Corporate Affairs (CA) for Alzheimer's disease will play a crucial role in supporting both the development and implementation of international strategies to improve the detection, diagnosis, and care of Alzheimer's disease. Through a...

  • Director, Global Medical Affairs Strategy

    4 maanden geleden

    Utrecht, Nederland Genmab Voltijd

    The Role The Genmab pipeline comprises of robust and diverse antibody products in immuno-oncology and beyond. Reporting to the Global Medical Affairs Strategy Lead (MASL) the Director will be responsible for the development and execution of the Global Medical Affairs strategic and tactical plans for the asset(s) for the primary indication as well as new...

  • Associate Director, Qp Operations

    4 maanden geleden

    Utrecht, Nederland Bristol-Myers Squibb Voltijd

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • (Associate) Director, Biostatistician

    4 maanden geleden

    Utrecht, Nederland Genmab Voltijd

    At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...

  • Senior Regulatory Affairs Manager Benelux

    2 weken geleden

    Utrecht, Nederland Elanco Voltijd

    Responsibilities:Drive life-cycle management and maintenance of existing products,Ensure successful roll-out of new products,Oversee and align Elanco’s global strategy on a local level,Ensure regulatory compliance to support key business operations,Facilitate strong cross-functional communication with internal and external partners,Proactively prioritize...

  • Associate Director Holdings Controller

    3 maanden geleden

    Utrecht, Nederland Bristol-Myers Squibb Voltijd

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Global Medical Strategy Director

    2 weken geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About the RoleThe Director, Global Medical Affairs Strategy will play a critical role in driving the development and execution of the Global Medical Affairs strategic and tactical plans for Genmab's asset(s) in the field of solid tumors.Key ResponsibilitiesStrategic Planning: Lead annual medical planning for asset(s) and work closely with extended medical...

  • Associate Director of Finance Operations

    4 dagen geleden

    Utrecht, Utrecht, Nederland Bristol Myers Squibb Voltijd

    Job SummaryWe are seeking a highly skilled and experienced Finance Associate Director to lead our finance operations for all our Holdings entities in the Netherlands. As the Finance Associate Director, you will play a critical role in overseeing financial activities, providing strategic guidance, and ensuring compliance with regulatory requirements.Key...

  • Associate Director, QA GCP/PV

    4 maanden geleden

    Utrecht, Nederland Genmab Voltijd

    At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...