Regulatory Strategist (Manager)

Pfizer

看过: 140

更新日: 16-11-2025

位置: Elsene Brussels Capital

类别: 执行管理 其他

行业: Pharmaceuticals

水平: Mid-Senior level

工作类型: Full-time

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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 Regulatory Strategist (Manager) to join our Vaccines Global Regulatory Affairs team. This is an excellent opportunity to join a growing and dynamic team and be in charge of various projects across different franchises. We are looking for candidates with a dynamic and agile profile with a scientific background, and regulatory experience. The candidate should be passionate for vaccines, willing to learn and advance in their career.

The Position
  • Reports to the Global Regulatory Lead
  • Assist in developing and implementing regulatory strategy that aligns with business needs, including growth projects and activities relating to maintaining registrations, product defense and regulatory compliance
  • Contribute to regulatory strategy and operational activities for projects/products (including across different franchises within Department): preparation and submission of correspondence and applications to regulatory agencies.
  • Participate in Regulatory and cross functional teams for assigned projects/products.
  • With appropriate supervision, direct and/or indirect liaison with Health Authorities (in conjunction with Country Regulatory Leads (CRLs)) to facilitate the prompt review and approval of applications, supplements/variations, and commitment closures.
  • Implementing systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring the sharing of information and learnings across the relevant lines.
  • Plays a supporting role in any appropriate activities in order to influence the regulatory environment through Agency contacts and Trade Associations as appropriate.
  • This is an individual contributor role.
  • Possible location(s) : Brussels (Belgium), or any European Pfizer location. For this position we do not offer relocation.
Please Note: This is a Clinical Regulatory Affairs position, not a CMC/Facilities Regulatory Affairs position. The candidate must be able to provide operational and strategic regulatory support and contribution to the areas of global clinical development, registration plans, labelling, licensure, and post-marketing commitments/post-authorization safety surveillance.

Your Skills
  • Education: Bachelor degree in a science subject together with appropriate pharmaceutical industry experience gained within a global regulatory affairs function. Understanding of vaccines and immunology advantageous.
  • Knowledge of the regulatory environment and how this impacts regulatory strategy development and implementation and awareness of the functioning of the pharmaceutical industry
  • Ability to manage complex issues with appropriate support, such as global and/or regional regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management or leveraging regulatory policy issues to support commercial objectives trong problem solving skills
  • Strong written and verbal communication skills. Ability to work well with appropriate level of independence and appropriate level of supervision
  • Language: English
Our offer

At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence.Our breakthrough culture lends itself to our dedication to transforming millions of lives. Pfizer’s open-door policy is an integrated part of our culture across all levels of seniority.

We offer possibilities for working from home and flexible working hours as per local Pfizer policies.

Competitive salaries and benefit packages.

Unparalleled opportunities for career growth: trainings, possibilities for internal mobility, temporary assignments…

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. Should you have any question or specific needs (including disability), please contact : Albena.Zabtcheva@Pfizer.com. We kindly ask you not to use this email address to apply. Interested? Click on the “apply” button !

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.beand on Facebook and Twitter.

Regulatory Affairs

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最后期限: 31-12-2025

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