Kickstart Your Pharma Career with a Regulatory Operations Assistant Job at Fortrea | Apply Now
Looking for a Regulatory Affairs Job as a fresher? This Pharma freshers’ job at Fortrea in Mumbai is a perfect opportunity to kickstart your career in regulatory operations. Gain hands-on experience in global submissions, GMP practices, and pharmaceutical documentation while building a strong foundation in the pharma industry.
- Job Title: Regulatory Operations Assistant I
- Location: Mumbai
- Job Requisition ID: 26655
About the Company
Fortrea is a leading global contract research organization (CRO) that supports pharmaceutical, biotechnology, and medical device companies in accelerating clinical development. With a strong focus on innovation and compliance, Fortrea provides excellent exposure for candidates seeking a Regulatory Affairs Job.
Job 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.
Key Responsibilities
- Responsible for following 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 compliance with GLP & GDP, cGMP- Guideline & ICH Guidelines.
- Analysis of cleaning validation and process validation.
- Responsible for performing 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
- Bachelor’s in Pharmacy or related science degree (or equivalent); OR Advanced Degree (e.g., PhD or Master’s) as applicable.
- Fortrea may consider relevant and equivalent experience instead of educational requirements.
- Speaking English and/or other languages as applicable.
- Knowledge of Management Information System (MIS) and electronic data management system (e.g, Regulatory Information Management, etc.) will be preferred.
- A diploma or Certification in Regulatory Affairs will be preferred.
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 the 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.
