Fortrea is hiring for the position of Regulatory Operations Specialist I in Mumbai, India. This is a full-time opportunity involving quality and compliance activities in support of the Clinical Supply Quality function.
The role focuses on reviewing and approving pharmaceutical quality documents, managing quality issues, CAPA and change controls, supporting risk assessments and maintaining compliance with procedures and customer requirements.
Candidates with a Bachelor’s or Master’s degree in Pharmaceutical, Chemical, Biological Sciences or a related scientific discipline and at least 5–7 years of pharmaceutical industry experience, preferably in Quality Assurance, may be eligible for this position.
The application deadline listed for the vacancy is October 10, 2026.
Fortrea Regulatory Operations Specialist I – Job Highlights
| Particular | Details |
|---|---|
| Company | Fortrea |
| Job Title | Regulatory Operations Specialist I |
| Location | Mumbai, India |
| Job Type | Full Time |
| Experience | 5–7 Years |
| Qualification | Bachelor’s / Master’s degree in Pharmaceutical, Chemical or Biological Sciences, or equivalent experience |
| Preferred Experience | Pharmaceutical Industry / Quality Assurance |
| Department / Function | Clinical Supply Quality / Quality Assurance |
| Work Environment | Office or Remote |
| Requisition ID | 265581 |
| Application Deadline | October 10, 2026 |
| Salary / CTC | Not specified |
About Fortrea
Fortrea is a global clinical research organization that supports pharmaceutical, biotechnology and healthcare companies across clinical development and related research activities.
The Regulatory Operations Specialist I role supports quality-related activities and works with internal departments, contract laboratories, clients and other stakeholders to maintain quality standards and regulatory compliance.
Job Description
The Regulatory Operations Specialist I will support the Clinical Supply Quality team with quality assurance and compliance activities.
The position involves reviewing pharmaceutical quality documentation, handling quality issues, CAPA and change controls, participating in quality-focused meetings and supporting risk management activities.
The successful candidate will also work with different business and quality stakeholders to identify improvement opportunities, resolve issues and strengthen the overall quality culture.
Regulatory Operations Specialist I – Role Overview
This role is primarily focused on pharmaceutical quality, compliance, risk management and continuous improvement.
The professional will be expected to review technical documentation, contribute to quality investigations, support corrective and preventive actions, assess risks and ensure that applicable procedures and customer requirements are followed.
The scope of responsibilities may evolve depending on business and Quality Assurance requirements.
Educational Qualification
Candidates should have:
- A Bachelor’s degree in a scientific discipline; or
- A Master’s degree in a scientific discipline.
Relevant fields include:
- Pharmacy
- Pharmaceutical Sciences
- Chemistry
- Biological Sciences
- Related scientific disciplines
Equivalent professional experience may also be considered according to the vacancy requirements.
Experience Requirements
Candidates should have:
- At least 5–7 years of experience in the pharmaceutical industry.
- Experience in Quality Assurance is preferred.
- Experience with pharmaceutical quality processes and compliance activities is relevant to the position.
Key Responsibilities
Quality Document Review and Approval
The selected professional will support the Clinical Supply Quality team by:
- Reviewing and approving relevant quality documents.
- Assessing protocols and reports associated with method qualification.
- Reviewing method validation documentation.
- Reviewing method transfer-related documentation.
- Supporting the review of investigation documents.
- Giving particular attention to microbiology-related quality documents and non-conformances.
Quality Issues and CAPA Management
Responsibilities include:
- Handling quality issues involving clients and contract laboratories.
- Supporting Corrective and Preventive Action (CAPA) activities.
- Participating in change control processes.
- Tracking and addressing quality-related concerns.
- Supporting actions designed to prevent recurrence of quality issues.
Quality Culture and Continuous Improvement
The role will involve working with supported departments to:
- Maintain a strong quality culture.
- Promote continuous improvement.
- Contribute to improvements in Quality KPIs.
- Identify opportunities to strengthen quality processes.
- Support quality improvement initiatives across relevant functions.
Meetings and Quality Programs
The specialist may actively participate in meetings and programs such as:
- Quality Assurance / Clinical Supply Quality meetings
- CAPA boards
- Quality improvement programs
- Business connect meetings
Participation will depend on the requirements of the supported business functions.
Risk Assessment and Mitigation
The position will also support data-driven risk management activities, including:
- Identifying potential risks.
- Supporting risk analysis and evaluation.
- Developing or contributing to risk mitigation plans.
- Supporting CAPA-related initiatives.
- Using quality data to identify potential areas of concern.
Stakeholder Collaboration
The selected candidate will:
- Work with internal departments and business partners.
- Build effective working relationships with stakeholders.
- Collaborate with clients and contract laboratories where required.
- Identify opportunities for process improvement.
- Support business and quality objectives.
- Communicate quality-related concerns and solutions effectively.
Issue Resolution and Compliance
Responsibilities also include:
- Identifying potential quality or compliance issues.
- Performing troubleshooting activities.
- Supporting conflict resolution.
- Providing practical solutions where applicable.
- Ensuring compliance with applicable procedures.
- Ensuring customer requirements are appropriately addressed.
Required Skills
Candidates should demonstrate:
- Strong understanding of pharmaceutical quality processes.
- Quality Assurance experience.
- Knowledge of CAPA and change control.
- Ability to review technical and quality documentation.
- Risk assessment and mitigation skills.
- Problem-solving and troubleshooting ability.
- Strong attention to detail.
- Effective communication skills.
- Stakeholder management and collaboration.
- Ability to work independently and with cross-functional teams.
- Commitment to quality and compliance.
Work Location and Work Environment
- Location: Mumbai, India
- Job Type: Full Time
- Work Environment: Office or Remote
- Function: Clinical Supply Quality / Quality Assurance
The vacancy specifically indicates that the work environment may be office-based or remote.
Salary / CTC
Fortrea has not specified the salary or CTC for the Regulatory Operations Specialist I position in the available vacancy information.
Candidates should confirm compensation and other employment terms during the recruitment process.
Selection Process
The detailed selection process has not been specified in the provided vacancy information.
Candidates may be evaluated based on their pharmaceutical industry experience, Quality Assurance background, technical knowledge, quality documentation experience, problem-solving ability and understanding of compliance requirements.
How to Apply for Fortrea Regulatory Operations Specialist I
Interested and eligible candidates should submit their application through Fortrea’s official careers platform before the stated deadline.
Application Deadline
October 10, 2026
Candidates should review the complete job requirements and submit their application before the vacancy closes.
Important Details Before Applying
- The hiring company is Fortrea.
- The position is Regulatory Operations Specialist I.
- The job location is Mumbai, India.
- This is a full-time opportunity.
- The required experience is 5–7 years in the pharmaceutical industry.
- Quality Assurance experience is preferred.
- A Bachelor’s or Master’s degree in a relevant scientific discipline is required.
- Relevant fields include pharmaceutical, chemical and biological sciences.
- The role supports the Clinical Supply Quality team.
- Work may be performed in an office or remote environment.
- The requisition ID is 265581.
- The application deadline is October 10, 2026.
- Salary/CTC has not been disclosed.
Frequently Asked Questions
1. What is the job title at Fortrea?
The position is Regulatory Operations Specialist I.
2. Where is this Fortrea job located?
The position is based in Mumbai, India.
3. What experience is required?
Candidates should have 5–7 years of experience in the pharmaceutical industry, preferably within Quality Assurance.
4. What educational qualification is required?
A Bachelor’s or Master’s degree in a scientific discipline such as Pharmaceutical, Chemical or Biological Sciences is indicated.
5. Is Quality Assurance experience preferred?
Yes. The vacancy specifically mentions pharmaceutical industry experience, preferably in the Quality Assurance department.
6. What are the major responsibilities?
The role includes quality document review, method qualification/validation/transfer documentation, quality issues, CAPA, change controls, risk assessments, quality improvement and compliance activities.
7. Will the candidate work with contract laboratories?
Yes. The role includes handling quality-related activities involving clients and their contract laboratories.
8. Is CAPA experience relevant?
Yes. Supporting and handling Corrective and Preventive Action (CAPA) initiatives is part of the role.
9. Is the job remote?
The vacancy states that the work environment may be office or remote.
10. What is the requisition ID?
The requisition ID is 265581.
11. What is the application deadline?
The listed application deadline is October 10, 2026.
12. What is the salary for this Fortrea position?
The salary or CTC has not been specified in the available job information.
Important Note
Recruitment details, eligibility criteria, work arrangements, application deadlines and other employment conditions may change. Candidates should verify the latest information on Fortrea’s official careers platform before applying and should rely on the employer’s official communication for final recruitment terms.