Fortrea is hiring for the position of Regulatory Operations Principal Specialist in Mumbai, India. This is a full-time opportunity involving regulatory operations, project management, analytical science and pharmaceutical development activities.
The role combines regulatory operations with scientific and project-management responsibilities. The selected professional will support Fortrea clients across the product lifecycle, including regulatory and technical documentation, analytical and dissolution projects, client coordination, contract laboratory management, quality activities and regulatory submissions.
Candidates with a relevant Bachelor’s or advanced degree and approximately 7–9 years of experience in areas such as Regulatory Affairs, Quality Assurance, Analytical Science, Packaging, Formulation Science, Material Management or related pharmaceutical disciplines may be eligible.
The position also requires knowledge of in-vitro and comparative dissolution testing, regulatory guidelines such as FDA-SUPAC and ICH requirements, analytical techniques and pharmaceutical product development.
Fortrea Regulatory Operations Principal Specialist – Job Highlights
| Particular | Details |
|---|---|
| Company | Fortrea |
| Job Title | Regulatory Operations Principal Specialist |
| Location | Mumbai, India |
| Job Type | Full Time |
| Experience | 7–9 Years |
| Qualification | Bachelor’s / Master’s / PhD or relevant equivalent experience |
| Key Areas | Regulatory Operations, Dissolution Testing, Analytical Science, Project Management |
| Regulatory Scope | US, EU, Japan and ROW markets |
| Preferred Experience | Project Management and People Management |
| Work Environment | Office or Remote |
| Travel | Approximately 5–10% as required |
| Requisition ID | 265583 |
| Application Deadline | October 9, 2026 |
| Salary / CTC | Not specified |
About Fortrea
Fortrea is a global clinical research organization supporting pharmaceutical, biotechnology and healthcare companies in clinical development and related research activities.
The Regulatory Operations Principal Specialist role supports client projects through regulatory, scientific, quality and operational activities. The position involves collaboration with clients, contract laboratories, suppliers, CROs and internal teams to support project delivery and regulatory compliance.
Job Description
The Regulatory Operations Principal Specialist will manage and support regulatory operations and project activities across the pharmaceutical product lifecycle.
The role includes overseeing the creation, revision, compilation and approval of regulatory, technical and labeling documents for submission to health authorities in markets such as the United States, European Union, Japan and other regions.
In addition to regulatory operations, the position has significant responsibilities related to dissolution studies, analytical testing, scientific investigations, technical documentation and project management.
Regulatory Operations Principal Specialist – Role Overview
The position is designed for an experienced pharmaceutical or scientific professional who can combine technical expertise with regulatory and project-management capabilities.
The selected candidate may lead teams, coordinate project resources, interact with clients and laboratories, support audits and contribute to process improvements while ensuring that deliverables meet applicable quality and regulatory expectations.
Educational Qualification
Candidates may qualify through one of the following pathways.
Pharmaceutical or Scientific Background
- Bachelor’s degree in Pharmacy or a related scientific discipline; or
- Advanced degree such as a Master’s or PhD with relevant experience.
- Relevant and equivalent professional experience may be considered in place of formal educational requirements, according to Fortrea’s stated criteria.
Packaging-Related Background
The vacancy also provides an alternative pathway for candidates with:
- Bachelor’s degree in Engineering/B.Tech in Packaging, Polymer or Printing-related streams with relevant packaging experience; or
- Postgraduate qualification, diploma or certification in Packaging with relevant experience.
The source indicates that relevant equivalent experience may be considered in lieu of educational requirements.
Experience Requirements
The position generally requires 7–9 years of experience in the relevant job discipline.
Relevant backgrounds may include:
- Regulatory Affairs
- Quality Assurance
- Analytical Science
- Packaging
- Polymer or Printing
- Formulation Science
- Material Management
- Drug Development
- Pharmaceutical Manufacturing
At least 1 year of project management and people management experience is desirable.
Dissolution Testing Experience
A significant part of the role involves dissolution-related scientific work. Candidates should have knowledge or experience in:
- In-vitro dissolution testing
- Comparative dissolution testing
- Multimedia dissolution testing
- Dissolution investigations
- Dissolution data analysis
- Scientific interpretation of dissolution datasets
- Troubleshooting dissolution-related issues
Knowledge of regulatory expectations surrounding dissolution studies is also important.
Regulatory Knowledge
Candidates should understand regulatory guidance associated with pharmaceutical development and dissolution studies, including:
- FDA-SUPAC guidance
- ICH guidelines
- Validation requirements
- Regulatory expectations in emerging markets
- China regulatory requirements
- Latin American regulatory requirements
- GxP requirements
- ICH-GCP guidelines
- Pharmaceutical product lifecycle requirements
A strong understanding of regulatory and compliance requirements is expected for this senior-level role.
Analytical Techniques and Laboratory Skills
The vacancy calls for hands-on experience with a range of analytical techniques and their troubleshooting, including:
- HPLC
- GC
- UPLC
- KFT
- Particle size measurement
- GC-MS
Experience troubleshooting analytical instruments and methods is particularly relevant.
Key Responsibilities
Regulatory Operations and Project Management
The selected professional will:
- Perform regulatory operations and project-management activities for Fortrea clients.
- Coordinate regulatory activities across applicable product lifecycle stages.
- Manage the creation, revision, compilation and approval of regulatory documents.
- Support preparation of regulatory and labeling documents for health authority submissions.
- Coordinate deliverables according to agreed timelines.
- Support regulatory activities covering the US, EU, Japan and other applicable markets.
- Work with senior management to support resource allocation across projects.
- Manage assigned team members and support performance-related activities.
- Assist with human-resource matters affecting the project team.
Team Management
Responsibilities may include:
- Supporting team performance management.
- Assisting with resource planning.
- Training and mentoring project team members.
- Providing technical and operational guidance.
- Cascading important information from internal and external meetings to relevant colleagues.
- Supporting effective team collaboration and delivery.
Analytical and Dissolution Projects
The role will also support analytical projects, including:
- Providing analytical support for developmental projects.
- Supporting comparative dissolution projects.
- Designing scientific experiments.
- Monitoring laboratory activities.
- Reviewing experimental results.
- Recommending expansion or reduction of investigations based on scientific findings.
- Analyzing dissolution datasets.
- Interpreting scientific results and drawing conclusions.
- Troubleshooting analytical instruments and methods.
Technical Documentation
The specialist may be responsible for preparing and reviewing:
- Test methods
- Technical documents
- Protocols
- Scientific reports
- Regulatory documentation
- SOPs
- Work Instructions
- Training materials
The role also requires accurate recording and retention of information, records and raw data.
Contract Laboratory and CRO Coordination
The selected candidate will work as an interface between:
- Contract laboratories
- CROs
- Suppliers
- Clients
- Customers
- Internal colleagues
The objective is to establish clear project expectations, improve performance and ensure that projects are completed within agreed timelines.
Quality and GMP Compliance
Responsibilities include:
- Performing activities according to applicable GMP and safety requirements.
- Supporting quality assurance activities.
- Ensuring appropriate documentation and data retention.
- Working with Fortrea’s Quality Assurance team.
- Supporting development of SOPs and training materials.
- Providing training where appropriate.
- Maintaining compliance with applicable procedures and regulatory expectations.
Client Management
The professional will:
- Work closely with clients to support satisfaction.
- Help ensure successful project transition and delivery.
- Monitor service delivery against applicable Service Level Agreements.
- Participate in client discussions and project meetings.
- Communicate project information and technical findings appropriately.
Process Improvement
The position will contribute to:
- Process improvement initiatives.
- Productivity improvements.
- Operational efficiency.
- Development and refinement of procedures.
- Identification and resolution of technical or operational issues.
- Improvements in project execution and service delivery.
Audit and Inspection Support
The candidate will:
- Prepare for client audits.
- Support regulatory agency audits where required.
- Participate in audit activities.
- Help address technical or operational issues identified during audits.
- Maintain appropriate documentation and compliance records.
Required Professional Skills
Candidates should demonstrate:
- Strong analytical and scientific skills
- Project-management capability
- People-management skills
- Decision-making ability
- Problem-solving skills
- Strong communication and presentation skills
- Planning and execution capability
- Collaborative working style
- Customer-focused approach
- Leadership capability
- High attention to detail
- Ability to work in a regulated environment
- Ability to identify and resolve problems
- Strong organizational and time-management skills
Pharmaceutical Product Lifecycle Knowledge
A good understanding of the pharmaceutical product lifecycle is preferred for this role.
The candidate should be comfortable working across development, analytical, manufacturing, quality and regulatory activities and understand how these functions contribute to pharmaceutical product development and maintenance.
Data and Documentation Skills
Knowledge or experience with the following is beneficial:
- Data management systems
- Management Information Systems (MIS)
- Document management systems
- Publishing tools
- Microsoft Office applications
- Regulatory documentation
- Technical records
- Raw data management
Work Location and Work Environment
- Location: Mumbai, India
- Job Type: Full Time
- Work Environment: Office or Remote
- Travel: Approximately 5–10% regional or global travel, including overnight stays when required by project needs.
The vacancy specifically states that the role may be performed in an office environment or remotely.
Salary / CTC
Fortrea has not specified the salary or CTC for the Regulatory Operations Principal Specialist position in the available vacancy information.
Candidates should confirm compensation and other employment terms during the official recruitment process.
Selection Process
The detailed selection process has not been specified in the vacancy information.
Given the seniority of the role, candidates may be assessed on their regulatory operations experience, analytical and dissolution expertise, pharmaceutical industry background, project-management capabilities, leadership skills, regulatory knowledge and ability to work with clients and cross-functional teams.
How to Apply for Fortrea Regulatory Operations Principal Specialist
Interested and eligible candidates should submit their application through Fortrea’s official careers platform before the stated deadline.
Application Deadline
October 9, 2026
Candidates should review the complete requirements and submit their application before the vacancy closes.
Important Details Before Applying
- The company is Fortrea.
- The position is Regulatory Operations Principal Specialist.
- The job location is Mumbai, India.
- This is a full-time opportunity.
- The expected experience is approximately 7–9 years in a relevant discipline.
- A Bachelor’s degree in Pharmacy or a related scientific field may qualify.
- Relevant advanced degrees and equivalent experience may also be considered.
- Packaging, Polymer and Printing-related educational backgrounds are included under an alternative eligibility pathway.
- Experience with in-vitro, comparative and multimedia dissolution testing is important.
- Knowledge of FDA-SUPAC and ICH guidance is relevant.
- Experience with HPLC, GC, UPLC, KFT and particle-size measurement is relevant.
- GC-MS expertise is listed in the vacancy.
- Project management and people management experience of at least 1 year is desirable.
- The role may involve 5–10% regional or global travel.
- The work environment may be office or remote.
- The requisition ID is 265583.
- The application deadline is October 9, 2026.
- Salary/CTC has not been disclosed.
Frequently Asked Questions
1. What is the job title at Fortrea?
The position is Regulatory Operations Principal Specialist.
2. Where is the Fortrea job located?
The position is based in Mumbai, India.
3. How much experience is required?
The vacancy indicates approximately 7–9 years of experience in the relevant job discipline.
4. Is Pharmacy a suitable qualification?
Yes. A Bachelor’s degree in Pharmacy or a related scientific discipline is one of the stated educational pathways.
5. Is an advanced degree preferred?
Yes. Master’s or PhD-level qualifications with relevant experience are included in the requirements.
6. What type of dissolution experience is required?
The role calls for knowledge of in-vitro, comparative and multimedia dissolution testing, including dissolution investigations and data interpretation.
7. Which analytical techniques are relevant?
The vacancy mentions HPLC, GC, UPLC, KFT, particle size measurement and GC-MS, along with troubleshooting experience.
8. Is project management experience required?
At least 1 year of project management and people management experience is desirable.
9. Will the role involve regulatory submissions?
Yes. The position supports regulatory operations and documentation for submission to health authorities across the US, EU, Japan and other applicable markets.
10. Does the position require travel?
Yes. The vacancy indicates approximately 5–10% regional or global travel, including overnight stays when required.
11. Is remote work available?
The vacancy states that the work environment may be office or remote.
12. What is the requisition ID?
The requisition ID is 265583.
13. What is the application deadline?
The listed deadline is October 9, 2026.
14. What is the salary for this Fortrea position?
The salary or CTC has not been specified in the available vacancy information.
Important Note
The vacancy contains an apparent typographical inconsistency in one section where packaging experience is written as “79 years.” Other sections consistently indicate 7–9 years, which has been reflected in this article. Candidates should verify the latest official eligibility requirements with Fortrea before applying.
Recruitment requirements, work arrangements, travel expectations, application deadlines, compensation and other employment conditions may change. Candidates should rely on Fortrea’s official careers platform and recruitment communication for the latest information.