Regulatory Intelligence Lead - Biologics/Vaccines M/V/X

Beschrijving van de functie

De Pfizer site in Puurs is één van de grootste productie- en verpakkingssites van Pfizer wereldwijd, gespecialiseerd in aseptische productie en verpakking. Jaarlijks worden in Puurs meer dan 400 miljoen doses injecteerbare vaccins en medicijnen geproduceerd. Deze zijn ter plaatse verpakt in ampullen, flacons, plastic flessen, spuiten en patronen voor pennen.

De medicijnen die in Puurs worden gemaakt, zijn bestemd voor patiënten in meer dan 170 landen wereldwijd. 30% van de productie uit Puurs is bestemd voor ontwikkelingslanden, in samenwerking met UNICEF, WHO, GAVI en ngo's.

Met het gebruik van twee windturbines, zonnepanelen en een warmtekrachtcentrale richten we ons op hernieuwbare energie.

Pfizer's doel is om gelijke kansen te bieden in het wervingsproces door elke vorm van vooringenomenheid of mogelijke discriminatie te vermijden, ongeacht (maar niet beperkt tot) geslacht, leeftijd, ras, religie of overtuiging, seksuele geaardheid of handicap. We creëren een organisatie en bevorderen een cultuur die respect heeft voor ieders unieke karakter en levenservaringen en die de diversiteit van onze samenleving, klanten en markten weerspiegelt. Dit bereiken we door een omgeving te cultiveren en in stand te houden waarin elke collega zich gewaardeerd en ondersteund voelt.

Disability Inclusion:

Onze missie is om de kracht van al onze mensen te ontwikkelen en ruimte te geven. We zijn trots om een inclusieve werkgever te zijn, die aan alle kandidaten met een beperking gelijke kansen biedt.

Role Summary The Regulatory Intelligence Lead for Biologics and Vaccines is a highly visible, enterprise leadership role responsible for shaping and advancing global regulatory intelligence and policy to enable quality and compliance excellence across Pfizer Global Supply (PGS) and Pharmaceutical Sciences. Operating at the intersection of science, policy, and strategy, this role drives the proactive monitoring, interpretation, and influence of global cGMP regulations and guidelines, translating insights into impactful Quality Standards (policies and procedures) that support breakthrough therapies. With global scope, this role serves as a key strategic partner to senior leadership and external stakeholders, representing Pfizer in international regulatory forums and influencing the evolving regulatory landscape. The position is central to advancing innovative biologics and vaccine platforms while strengthening Pfizer's inspection readiness and compliance posture worldwide. This role offers a unique opportunity to influence global regulatory policy, shape industry standards, and directly impact the successful delivery of innovative biologics and vaccines to patients. Role Responsibilities Define and lead the global regulatory intelligence strategy for Biologics and Vaccines, ensuring proactive identification, interpretation, and prioritization of evolving regulatory requirements to enable enterprise-wide readiness and competitive advantage. Act as a senior industry representative in global regulatory forums, trade associations, and health authority engagements (e.g., EFPIA, EMA, MHRA, ICH, etc.), shaping emerging regulations and advocating for science- and risk-based approaches aligned with Pfizer's strategic priorities. Serve as a trusted advisor to executive and senior leaders, providing expert interpretation of regulatory intelligence and exercising sound judgment to influence strategic decisions, regulatory positioning, and implementation approaches. Partner across global process owners, quality, regulatory, and technical organizations to ensure consistent understanding and application of regulatory expectations, driving alignment on critical compliance and quality initiatives. Transform regulatory intelligence capabilities through digital tools, advanced analytics, and new operating models to enhance speed, quality, and impact of insights across the organization.

Jouw profiel

Qualifications Basic Qualifications Bachelor's degree in a scientific, regulatory, or related discipline with minimum 8+ years of experience in the pharmaceutical, biotechnology, or related regulated industry. Demonstrated experience in regulatory intelligence, including monitoring, interpreting, and influencing global regulatory requirements. Proven track record of representing an organization externally with regulatory authorities, industry associations, or consortia. Strong experience leading complex, cross-functional initiatives with global scope, including the ability to manage competing priorities, deliver to tight timelines, and adapt to evolving requirements. Demonstrated change agility and ability to operate effectively in high-complexity, fast-changing environments. Proven ability to mentor, coach, and develop talent, contributing to a high-performing and collaborative organization. Advanced critical thinking and problem-solving skills, including the ability to synthesize complex regulatory information, anticipate implications, and translate insights into strategic actions. Demonstrated ability to drive continuous improvement and operational excellence, including identifying and implementing innovative solutions. Exceptional communication and influencing skills (written and verbal), with the ability to engage and align diverse internal and external stakeholders at all levels of the organization. Preferred Qualifications Advanced degree (e.g., MS, PhD, MBA, or equivalent) in relevant scientific, regulatory, or business discipline. Recognized industry leadership experience, including active participation or leadership roles in trade/professional associations (e.g., EFPIA, ISPE, PDA). Experience influencing or contributing to global regulatory policy development or consultation processes. Demonstrated experience in biologics and/or vaccine platforms, including an understanding of modality-specific regulatory expectations. Fluency in English (additional languages considered an asset for global engagement). Organizational Relationships Internal Relationships This role operates within a highly matrixed, global environment and requires strong collaboration across internal leadership teams, functional experts, and external stakeholders to enable effective regulatory intelligence and policy influence, including Quality, Safety and Environmental Operations (QSEO), QSEO Leadership Team, Pfizer Global Supply Leadership Team specifically Quality Operations Leaders, Site Leaders, Site Quality Leaders, Regulatory Affairs, Quality and Compliance Risk Committees. External Relationships Engages with global regulators (e.g., FDA, EMA, MHRA, WHO, Health Canada, and other regional agencies) to monitor, interpret, and influence evolving regulatory expectations. Represents Pfizer in leadership roles within organizations such as EFPIA, ISPE, PDA, and other relevant forums to shape regulatory policy and industry positions.

Taalvaardigheden

• Nederlands (troef)

  • Begrijpen : Vaardig - (C1)
  • Schrijven : Vaardig - (C1)
  • Lezen : Vaardig - (C1)
  • Spreken : Vaardig - (C1)