Regulatory Assistant II

FTBRL Fortrea Brazil Limitada; São Paulo; Presencial; BRL 140 000 - 210 000; Tempo integral

Resumo da oferta

Fortrea is seeking a Regulatory Affairs professional to prepare, review and compile quality (CMC) and regulatory documents for global submissions and lifecycle maintenance. You will liaise with cross-functional teams to support change control, labeling projects and data management.

The role requires 1–2 years in Regulatory Affairs/QA, proficiency with MS Office, and knowledge of GMP/GDP and ICH-GCP guidelines. Office environment or remote work options may be available.

Qualificações

• Bachelor's in Pharmacy or related science degree (or equivalent).
• 1–2 years of experience in Regulatory Affairs/QA/Drug development processes.
• Strong documentation and MS Office skills; working knowledge of GMP/GDP and ICH-GCP desirable.

Responsabilidades

• Create, review and approve regulatory documents for submissions to US, EU, Japan and ROW health authorities.
• Coordinate change controls, ensure proper documentation and remediation of OOS/OOT events.
• Support labeling projects, CSV validation, data management and training of new associates.

Conhecimentos

Regulatory Affairs

Quality Assurance

Documentation

ICH-GCP

Formação académica

Bachelor's in Pharmacy

Advanced Degree (PhD/Masters)

Ferramentas

Microsoft Office

Document Management Systems

Descrição da oferta de emprego

Job Overview

Responsible for creation/revision/compilation/approval of Specifications/Documents for submission by Fortrea clients to US, EU, Japan, and ROW health authorities and oversight of the same, as applicable.

Summary of Responsibilities

Prepare, compile and review product quality (CMC) and other regulatory documents to support product development or submissions to various countries across the world for product registrations or post approval life cycle maintenance, as applicable. Create/revise/approve raw material and packaging specifications, and other associated documents, as applicable. Coordinate and interact with cross functional teams/departments for evaluation/impact assessment of change control, review implementation strategy and required documentation governing the change and managing OOS, OOT or other product related changes, if needed. Support Financial Data Management, Business Plan file creation and maintenance, Supplier data management and PO creation, as required. Support for creation and update of global labeling documents, QC and other associated activities for the labeling projects, as applicable. Support stability data evaluation and report preparation, dissolution profile evaluation etc. as applicable. Perform literature survey and prepare various regulatory documents in support of excipients, APIs and/or drug products, as applicable. Coordinate with stakeholders to understand and support import license requirements, investigation report drafting, record management and document coordination with internal and external department, as applicable. Responsible for specifications setting/justification, ensuring the Quality level for Laboratory support, perform Computerized System Validation (CSV) and upgradation of existing systems/software, as applicable. Seek guidance from other team members and manager as needed and keep up to date knowledge of various regulatory guidelines required for pharmaceutical product registration and product life cycle maintenance. Implement the use of consistent, efficient, and quality processes to meet timelines and deliverables according to regulatory requirements, standard operating procedures and maintain a culture of high customer services. Timely escalation of unresolved issues to Internal and External (client) points of contact. Tracking and maintenance of metrics, performing and documenting quality check and highlighting trends. Maintain training related documentation as per Fortrea and client requirements. Support with onboarding, training and mentoring new associates. Other duties as assigned by management.

Qualifications (Minimum Required)

Bachelor's in Pharmacy or related science degree (or equivalent); OR Advanced Degree (e.g., PhD or Masters) as applicable. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Speaking-English and/or other languages as applicable.

Experience (Minimum Required)

1-2 Years of experience in the job discipline (e.g. Regulatory Affairs/Quality Assurance/Analytical Science / Pharmaceutics / material management and overall drug development and manufacturing process). Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools. Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable. Interpersonal skills, Proactive, Taking ownership, Precise, Goal oriented. Good organizational and time management ability. Good analytical capabilities and Customer focus. Good review skills and concern for quality.

Preferred Qualifications Include

Bachelor's in pharmacy or related science degree (or equivalent); OR Advanced Degree (e.g., PhD or Masters) with 1-2 years of relevant experience. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Knowledge of Management Information System (MIS) and electronic data management system (e.g: Regulatory Information Management, etc.) system will be preferred. Diploma or certification in Regulatory Affairs will be preferred.

Physical Demands/Work Environment

Physical demands: No special factor at this time. Work environment: Office environment or remote. Learn more about our EEO & Accommodations request here.

At Fortrea, we're all about turning the "impossible" into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.