Regulatory Assistant II - Temporary

FTBRL Fortrea Brazil Limitada; São Paulo; Teletrabalho; BRL 60 000 - 90 000; Tempo integral

Resumo da oferta

Fortrea Brazil is seeking a regulatory affairs professional responsible for creating, revising, and compiling quality and regulatory documents for global submissions and lifecycle maintenance. You will coordinate with cross-functional teams to assess changes, ensure documentation quality, and support labeling, CSV validation, and MIS usage.

The role requires a Bachelor's in Pharmacy or related science, 1–2 years of experience, and proficiency with Microsoft Office and document management tools;

Qualificações

• Bachelor’s in Pharmacy or related science degree or advanced degree.
• 1–2 years of experience in regulatory affairs/QA/pharmaceutics or related.
• Proficiency with Microsoft Office and document management/publishing tools.
• Knowledge of pharmaceutical product life cycle and regulatory requirements (GxP, ICH-GCP) desirable.

Responsabilidades

• Prepare, compile and review regulatory documents for submissions worldwide.
• Create/revise specifications and related documents.
• Coordinate with cross-functional teams for change control and investigations.
• Support labeling, data management and supplier data tasks.

Conhecimentos

Regulatory affairs

Quality assurance

Documentation management

Interpersonal skills

Time management

Formação académica

Bachelor’s in Pharmacy or related science degree

Advanced Degree (e.g., PhD or Masters)

Ferramentas

Microsoft Office

Document Management systems

MIS / Regulatory Information 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.