Regulatory Assistant II

Fortrea; Deutschland; Hybrid; EUR 52.000 - 70.000; Vollzeit

Zusammenfassung

Fortrea is seeking a Regulatory Affairs/Documentation specialist to manage creation, revision and approval of specifications and regulatory documents for submissions to US, EU, Japan and ROW health authorities. You will coordinate change controls, support labeling and stability data, and ensure compliance with GxP and ICH guidelines.

The role involves collaboration with multiple teams, document management, and mentoring new associates within a flexible office/remote environment.

Qualifikationen

• 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.

Aufgaben

• 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.
• Create/revise/approve raw material and packaging specifications, and other associated documents as applicable.
• Coordinate and interact with cross-functional teams for evaluation/impact assessment of change control and documentation.
• Support for creation and update of global labeling documents, QC and other activities for labeling projects.
• Support stability data evaluation and report preparation, dissolution profile evaluation, etc.
• Perform literature survey and prepare regulatory documents for excipients, APIs and/or drug products.

Kenntnisse

Interpersonal skills

Proactive

Ownership

Time management

Analytical skills

Customer focus

Quality review

Ausbildung

Pharmacy degree or related science

Advanced degree (PhD/Master)

Regulatory Affairs certification

Tools

MS Office

Regulatory DMS

RIMS/MIS knowledge

Jobbeschreibung

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

• These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual contributor globally:
• 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.