Global Regulatory Lead - Director

☞ Pfizer

看过: 155

更新日: 16-11-2025

位置: Elsene Brussels Capital

类别: IT-软件 IT-硬件/网络 信息技术 生产/工艺

行业:

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工作内容

Pfizer is the world ’ s premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

We have an exciting opportunity for a Director to join our V accines Global Regulatory Affairs team. This is an excellent opportunity to join a growing and dynamic team and be in charge of various projects. We are looking for candidates with a dynamic and agile profile with a scientific background, and strong regulatory experience. The candidate should be passionate for vaccines, willing to learn and advance in their career.

ThePosition

  • Provide strategic regulatory expertise as Global regulatory representative to Product Team(s).

  • Lead and coordinate a virtual global regulatory strategy team (GRST), encompassing regional regulatory colleagues from North America, Europe, Emerging Markets, Japan.

  • Through the GRST, develop, align, manage and implement the global regulatory strategy.

  • Be accountable for delivering the project goals and aligning the regulatory strategy with global and business regional needs.

  • Be accountable for timely submissions and approvals with commercially attractive labelling across the regions.

  • Be accountable for ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s).

  • Role likely to be combined with other Regulatory Role ( i.e. regional US or EU regulatory role and/or Regulatory Lead for other projects).

  • Project(s) assigned can be in development and/or at post-authorization stage

  • This is a people manager role.

  • This role can be taken up from Brussels (Belgium ), or any European Pfizer location . For this position we do not offer relocation.

Yourskills

  • Education:BS is required. MS, PharmD, PhD or MD preferred. Equivalent workplace experience can be considered.

  • Experience:Extensive direct regulatory experience with advanced knowledge of US FDA and EU regulations. Global and European VaccinesExperience preferred .

  • Leadership and negotiation skills: a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

  • Language: English

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 atwww.pfizer.com ,www.pfizer.be and on Facebook and Twitter.

Regulatory Affairs
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最后期限: 31-12-2025

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