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) :

- 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) :

- 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).
- 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.
- Positive 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.

Learn more about our EEO & Accommodations request here.

📌 Regulatory Operations Assistant I (Navi Mumbai)
🏢 Fortrea
📍 Navi Mumbai