Regulatory Affairs Manager GCMC

☞ Pfizer

看过: 160

更新日: 26-11-2025

位置: Elsene Brussels Capital

类别: IT-软件 IT-硬件/网络 信息技术 执行管理

行业:

工作类型: Full-time

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工作内容

Why Patients Need You
We’re looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.
Work Location Assignment: Flexible
What You Will Achieve
You will help Pfizer develop and implement chemistry, manufacturing and control (CMC) regulatory strategies for small and large molecule pharmaceuticals and devices to meet global regulatory requirements throughout the life cycle. You will participate in a variety of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post approval submissions, representing the company on communications and in meetings with health authorities, assessing impact of new regulations, manages regulatory documents, etc. You will also be in a position to negotiate with regulatory authority personnel to expedite approval of pending registrations and respond to queries.
As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
  • Provide guidance, lead/co-lead projects, manage own time to meet objectives, and plan resource requirements for projects across the Department.
  • Serve as a Chemistry Manufacturing and Control (CMC) strategist and project leader for projects within the global Essential Health portfolio, providing regulatory assessments and developing regulatory strategies with minimal supervision.
  • Responsible for the development of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control.
  • Contribute to Global Chemistry Manufacturing and Controls projects, initiatives & actions along with prioritizing assigned workload appropriately.
  • Investigate opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems.
  • Develop effective relationships with local and global internal partners, i.e., Research and Development, Pfizer Global Supply Worldwide Strategy and Regulatory Business Units, etc.
  • Leverage both technical and regulatory knowledge, to mitigate risks.
  • Execute regulatory policies and operational processes and delivery of high quality regulatory submissions.
  • Use technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation.
Must-Have
  • Bachelor’s Degree
  • 5+ years of experience
  • Relevant pharmaceutical development, Quality Assurance/ Quality Control (QA/QC), and/or manufacturing experience
  • Demonstrated commitment to scientific and regulatory integrity, quality compliance
  • CMC (Chemistry Manufacturing and Control) regulatory and quality expertise to prepare regulatory assessments, develop and contribute to global regulatory strategies with assistance from management for projects across all aspects of drug development or manufacturing lifecycle
  • Excellent planning, organizational and project management skills
  • Advanced skills in written and verbal communications
  • Competent working knowledge of computer based systems, such as Microsoft Office, controlled documentation systems
  • English (C1)
Nice-to-Have
  • Master’s degree
  • Relevant pharmaceutical experience
  • Experience in R&D/ Quality/technical areas

What do we offer?
Innovative company Pfizer has a pipeline full of innovative medicines for a variety of conditions. As a Pfizer colleague, you’ll have the opportunity to maximize the impact of medicines for patients in a variety of ways. In short, you make a real difference.
Development opportunities We are always looking for top talent. We believe you will never stop learning and there will always be a new opportunity for your development. That is why we have broad opportunities in the Dutch organization. There are regular opportunities for training or to gain experience in a different field or even advancement to an international position.
A culture where you can be yourself We are a large, international organization with people from all over the world. At Pfizer everyone should be able to be themselves, that’s what we strive for and live by.
Work/life balance At Pfizer, we know that if you really want to make an impact on people’s lives, it’s important that your people are at their best. That’s why we offer our colleagues good working conditions, such as an appropriate salary and opportunities to work from home. Working a lot of overtime is not the norm for us. We also believe that work and having fun should go hand in hand. That’s why, for example, you can participate in all kinds of activities outside of work.
Are you interested?
Do you know enough and have you decided to respond? We are curious about you and invite you to submit your application via the apply button below. You don’t have to worry about a deadline to respond. We keep looking until we have found the right candidate for this position.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
We kindly ask you to provide your application documents in English!

#LI-PFE
Pfizer discovers, develops, manufactures and distributes medicines and vaccines. Pfizer wants to contribute to better health and wellness for everyone, at every stage of life. Pfizer works with the government and other health partners to provide quality and accessible healthcare. The patient is central to this story.
Pfizer has four offices in Belgium with which it supports its Belgian and international activities: 1) Anderlecht, where the Pfizer Clinical Research Unit is located. This is a fully equipped phase 1 research center. With that of New Haven (US), it is one of two Phase 1 Pfizer research centers in the world, 2) Elsene , the Belgian headquarters, 3) Puurs , Pfizer’s production and packaging site, and 4) Zaventem, the international Pfizer’s Logistics Center.
More information can be found at
www.pfizer.com
,
www.pfizer.be
and on Facebook and Twitter.
Regulatory Affairs
#LI-PFE
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最后期限: 10-01-2026

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