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Regulatory Operations Specialist Ii

Fortrea
Fortrea
4-7 years
Not Disclosed
Mumbai, India
10 May 11, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Analytical Development / Dissolution Scientist (Project Support Role)

Company

Fortrea (pharmaceutical clinical research and development services organization)


Job Overview

This role focuses on providing analytical and dissolution testing support for pharmaceutical development projects, including comparative dissolution studies. You will work closely with internal teams, contract research organizations (CROs), and external stakeholders to ensure timely, accurate, and compliant delivery of scientific data.


Key Responsibilities

1. Analytical & Experimental Support

  • Provide analytical support for developmental and comparative dissolution projects

  • Design and execute scientific experiments

  • Monitor laboratory work and ensure accuracy of results

  • Troubleshoot issues related to instruments and analytical methods

  • Analyze dissolution data and interpret results


2. Documentation & Reporting

  • Prepare test methods, protocols, technical documents, and reports

  • Ensure proper recording, retention, and management of raw data

  • Summarize and interpret scientific data and draw conclusions

  • Maintain compliance with GMP documentation standards


3. Dissolution Testing Expertise

  • Perform multimedia dissolution testing

  • Conduct comparative dissolution studies

  • Support dissolution investigations

  • Apply knowledge of in-vitro dissolution methods

  • Basic understanding of oral solid dosage formulations


4. Regulatory & Compliance

  • Work in compliance with:

    • GMP (Good Manufacturing Practices)

    • FDA SUPAC guidelines

    • ICH guidelines

  • Understand global regulatory expectations (China, Latin America, etc.)

  • Support audits and regulatory inspections


5. Project & Stakeholder Management

  • Coordinate with CROs to ensure project timelines are met

  • Interface with contract labs, suppliers, customers, and internal teams

  • Ensure client satisfaction and adherence to service level agreements (SLAs)

  • Communicate project updates across stakeholders


6. Quality & Process Improvement

  • Support SOP creation, review, and implementation

  • Participate in training and mentoring of team members

  • Contribute to process improvement and operational efficiency initiatives

  • Support QA teams in documentation and compliance activities


7. Collaboration & Communication

  • Participate in cross-functional meetings

  • Share relevant updates with internal teams

  • Assist in knowledge transfer and training activities

  • Work closely with leadership on project objectives and processes


Required Qualifications

One of the following:

  • Bachelor’s/Master’s/PhD in Pharmacy or related science field (4–7 years experience preferred)
    OR

  • B.Tech / Engineering / Packaging / Polymer / Printing / related field with 4–7 years experience


Required Skills & Competencies

Technical Skills

  • Dissolution testing (in-vitro & comparative)

  • Analytical chemistry / pharmaceutical development

  • Knowledge of pharmaceutical product lifecycle

  • Understanding of regulatory frameworks (GxP, ICH-GCP, FDA SUPAC)

  • Microsoft Office and data/document management tools


Soft Skills

  • Strong analytical and problem-solving ability

  • Attention to detail and quality focus

  • Good communication and presentation skills

  • Ability to work in teams

  • Time management and organizational skills

  • Decision-making capability

  • Proactive and ownership-driven mindset


Preferred Skills

  • Experience with MIS or electronic regulatory systems

  • Regulatory Affairs certification

  • Knowledge of drug development and manufacturing processes

  • Packaging/material science background (advantageous)


Work Environment

  • Office-based or remote (depending on assignment)

  • May require travel based on business needs

  • Collaborative, regulated pharmaceutical R&D environment


Role Summary (Simple Explanation)

This is a pharmaceutical analytical development role focused on:

  • Dissolution testing of drug products

  • Data analysis and interpretation

  • Lab experimentation and troubleshooting

  • Regulatory compliance (FDA/ICH/GMP)

  • Working with CROs and global teams