[Hiring] Regulatory Operations Assistant I @Fortrea

Role Description

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.

• Follow GMP and safety practices in the organization.
• Analysis of Assay, Related substances, Laser Particle size and Residual solvents of API.
• Analysis of Assay, Related substances, Dissolution, Blend Uniformity, Content Uniformity of Finished products.
• Ensure compliance with GLP & GDP, cGMP- Guideline & ICH Guidelines.
• Analysis of cleaning validation and process validation.
• Perform tasks assigned by the HOD as required.
• Skilled at handling instruments such as pH meter, analytical balance, Karl Fisher, UPLC, GC, HPLC, Dissolution, Particle size Analyser, etc.
• 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

• 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.

Requirements

• 0-3 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 0-1 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.