Clinical Research Regulatory Coordinator

The Clinical Research Regulatory Coordinator is responsible (primarily or in supporting role) for all activities related to the submissions of clinical trials applications in the CTR online platform known as Clinical Trial Information System (CTIS). The submitted CTA comprises files destined to Ethics Committee(s) and to Regulatory/Competent Authorities. In addition, responsibility includes creating, initiating, coordinating, monitoring and maintaining clinical study site documentation.

JOB RESPONSIBILITIES

Preparation and Online submission of Clinical Trial Applications in CTIS

• Responsible for communication with the NCP, for preparing the required Part 1 and Part 2 files and completing CTA submissions in the CTIS platform.
• Responsible within the Regulatory Team to ensure that studies are conducted scientifically and ethically and in compliance with EMA/FDA/ICH/GCP guidance and regulations/laws.
• Lead the administrative regulatory work related to lifecycle maintenance and completion of trials (ASR, etc.), and ensure proper documentation and communications to relevant stakeholders.

Part 1: Competent Authorities files

• Coordinates with PCRU PIs and Pharmacists, RegCMC and Dev Ops colleagues to ensure timely availability and accuracy of all the required IMP-related documents.
• Coordinate and ensure the translations and redaction of relevant submission files for assigned protocols.

Part 2: Ethics Committees files

• Solicit input from local clinical teams on assigned synopses, protocols and Informed Consent Documents (ICDs) where appropriate.
• Ensure the accuracy of managed ICDs and their translations, as well as related regulatory documents for assigned protocols (recruitment strategy, all other participant-facing documents).

Other Activities

• Responsible for study-specific tasks such as site registration in CTMS, QC and filling of study documents in PTMF as well as maintenance and archiving of study files (ISF).
• Act as an SME for SOP updates and review within the functional line.
• Responsible for providing oversight on specialized regulatory related PCRU projects, including adoption and implementation of new operational tools in collaboration with PCRU New Haven.
• Liaison to the project teams for studies scheduled in the PCRU to provide inputs on regulatory aspects (EU CTR, Belgian law).
• Responsible for the implementation of new processes and work to proactively resolve issues where appropriate.
• Develop knowledge of the GDPR and optimize its implementation at the PCRU.
• Guide PCRU teams in accomplishing business needs and resolving issues.
• Represent the PCRU on local or global initiatives as a subject matter expert where appropriate.
• Give input in PCRU documentation to facilitate positive attitude and trust of participants toward clinical research.

Training

• Participate in training courses as appropriate, and train Regulatory team members with less experience and expertise.
• Assist in the training of PCRU staff and contractors with less experience and expertise.
• Responsible for complying with Pfizer Standards, ethical standards, ICH, regulatory and applicable legal requirements.

 

QUALIFICATIONS / SKILLS

• Bachelor’s degree in management, Life Sciences or equivalent, with relevant experience in Regulatory Affairs.
• A Master in the above-mentioned domains is preferred.
• Autonomous but with a strong team spirit
• Accountable, with very keen sense of initiative and leadership skills
• Strong organizational skills, multiple projects flexibility and very good resistance to stress or a high workload, with focus on the agreed timelines.
• Detail oriented, precise in oral and written communication
• Strong IT skills: advanced use of MS Office tools such as Outlook, Word, Excel, PowerPoint, Teams, OneNote; and eager to develop competence in using Pfizer approved AI tools.
• Min. 5 years of experience in pharma, of which at least some years in a regulatory environment
• Working knowledge of ICH and GCP guidelines required
• Strong understanding and knowledge of regulatory aspects of drug development
• Languages: Fluent in English and either French or Dutch (written and spoken)
• Scientific / Medical Knowledge:
  • Understanding of basic clinical pharmacology principles, with ability to review emerging safety and efficacy profile of a drug candidate and recognize potential serious adverse effects.
  • Demonstrated understanding of the complexities and recent developments in exploratory research.

• Participates to the successful study conduct of PCRU studies in accordance with ethical, legal, and moral standards, Good Clinical Practices, Good Laboratory Practices, PCRU management requests, Clinical Development and operations (CD&O) and R&D Pfizer goals.

ORGANIZATIONAL RELATIONSHIPS

• Reports to Clinical Operations Director
• Functional relationship to Clinical Research Regulatory Manager, and to Investigators in areas of regulatory and ethical oversight for volunteers/study participants.
• Matrixed relationship to US and Belgium regulatory teams, study teams, and peers in the PCRU-NH.

Work Location Assignment: On Premise

The closing deadline for applications is September 16th 2026.

Pfizer's aim is to provide equality of opportunity in the recruitment process by avoiding any bias or potential discrimination on any grounds including (but not limited to): sex, age, race, religion or belief, sexual orientation or disability. At Pfizer we are creating an organization and promoting a culture that respects each individual's unique character and life experiences and reflects the diversity of our society, customers and markets. We will achieve this through fostering and sustaining an environment in which every colleague feels valued and supported.

Disability Inclusion

Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!

Handicap & Inclusion

Notre mission est de libérer le potentiel de nos collaborateurs et nous sommes fiers d'être un employeur inclusif pour les personnes handicapées, garantissant ainsi l'égalité des chances en matière d'emploi pour tous les candidats. Nous vous encourageons à donner le meilleur de vous-même en sachant que nous apporterons tous les ajustements raisonnables pour soutenir votre candidature et votre carrière future. Votre expérience avec Pfizer commence ici !

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