Regulatory Associate

JOB TITLE:
Regulatory Associate, US focused

Reports To:
Head of Global PCRU Clinical Operations

DIVISION/BUSINESS LINE:
Global Product Development

VERSION DATE:
2023 Jan 13

SUBDIVISION:
Clinical Development & Operations

DEPARTMENT NAME:
PCRU

LOCATION(S):
_indicate Pfizer locations_)

Brussels, Belgium

JOB INFORMATION

JOB SUMMARY

Summarize the primary purpose & key accountabilities of the job.

The Regulatory Associate
- Provides support for all activities related to IRB submissions.
- Adds value to the business and ensures compliance by providing logistic and administrative support to the Regulatory Department by contributing to the preparation, follow-up, processing, implementation and electronic archiving of all regulatory submissions and activities to meet regulatory requirements, internal standards, and global objectives.
- Provide input / take initiative and follow-up all activities for timely and proper completion of required activities.

JOB RESPONSIBILITIES

Indicate the primary responsibilities critical to the job.
- Provide support to ensure timely and accurate IRB submissions.
- Provide support within the Regulatory Team to ensure that studies are conducted scientifically and ethically and in compliance with FDA/ICH/GCP guidance and regulation.
- Ensure that all local and global systems, tracking tools and databases are continuously and accurately updated with regulatory information.
- Develop processes for and coordinate ad hoc and routine QC checking of regulatory databases and systems and build expertise through management of operational processes and regulatory databases/systems
- In compliance with applicable local and corporate SOPs and best practices, manage and complete all regulatory system requirements in collaboration with Regulatory Affairs colleagues, by checking events and regulatory and submissions-related activities
- Provide the administrative work related to completion of trials (CSR, ASR, SUSAR, AE, etc.), communications to the IRB
- Ensure end of study reports are provided timely to IRB
- Act as a contributor to assigned regulatory system development projects
- May provide support to the management of trials when appropriate, and maintain accuracy, accessibility, and confidentiality in volunteer records and reports when doing so
- Provide support to the project teams for studies scheduled in the PCRU
- Support the implementation of new processes and work to proactively resolve issues where appropriate
- Manages the maintenance and archiving of study files

General administrative work:

- Provide support and back-up for administrative tasks as needed

Training
- Participate in training courses as appropriate
- 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 legal requirements, national and European laws on health and safety at work, fire prevention and other appropriate legislation.

QUALIFICATIONS / SKILLS

Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.

Minimum level of education:

- Bachelor degree in Management/(Medical) Secretarial Assistant, Life Sciences or equivalent, with relevant experience in Regulatory Affairs.

Functional / Professional Competencies Specific to the job:

- Autonomous but with a strong team spirit,
- Service-minded, accountable
- Strong administrative orientation
- Strong organizational skills, multiple projects flexibility
- Detail oriented, precise in oral and written communication
- Very keen sense of initiative,
- Very good resistance to stress and a high workload.
- Strong IT skills: advanced use of Outlook, Word, Excel and PowerPoint.

Experience: Min. 5 years of experience in the field of administration, secretarial work or office management, of which at least some years in a regulatory environment

Languages: Fluent in English (written and spoken)

ORGANIZATIONAL RELATIONSHIPS

Reports to Head of Global PCRU Clinical Operations

Work Location Assignment: Flexible
- 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 Logistic