Regulatory Operations Assistant I

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:

• Responsible to 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.

• Responsible for complainace of GLP & GDP cGMP- Guideline & ICH Guidelines.

• Analysis of cleaning validation and process validation.
• Responsible to perform the task assigned by the HOD as and when 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 (Minimum Required):

• Bachelors 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):

• 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:

• Bachelors 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.

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