Job Overview:

Responsible for creation/revision/compilation/approval of 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, upload and review of stability reports including compiling data tables, adding graphical representation of data, and drawing preliminary conclusions on the stability profile of the involved pharmaceutical product or active substance.
• Perform statistical evaluation of data to use of statistical software.
• Be accountable to assure quality and compliance with procedures and customer requirements.
• 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 manage OOS, OOT or other product related changes, if needed.
• 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.
• Maintain training related documentation as per Fortrea and client requirements.
• Other duties as assigned by management.

Qualifications (Minimum Required):

• Bachelor’s in Pharmacy or related science degree (or equivalent)
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Speaking-English and/or other languages as applicable.

Experience (Minimum Required):

• 0-1 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 such as analytical chemistry, bio chemistry, industrial engineer or equivalent with 0-4 years of relevant experience with analytics or stability (Formulations and bulk drugs) in a GMP environment with proven Scientific and Technical skills.
• 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.

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