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Fortrea Regulatory Operations Specialist I Job in Mumbai
Published on: September 30, 2026
Fortrea has listed a Regulatory Operations Specialist I position in Mumbai, Maharashtra. The role comes under the Clinical category and combines regulatory operations with quality activities, laboratory equipment management, validation and pharmaceutical documentation.
The position may be relevant to experienced professionals with backgrounds in B.Pharm, related sciences, Regulatory Affairs, Quality Assurance, analytical science, pharmaceutics and other relevant fields.
1. Fortrea Regulatory Operations Specialist I – Job Overview
| Particular | Details |
|---|---|
| Company | Fortrea |
| Position | Regulatory Operations Specialist I |
| Job ID | 265581 |
| Location | Mumbai, Maharashtra |
| Category | Clinical |
| Experience | 4–7 years in a relevant discipline |
| Qualification | B.Pharm / related science or other specified technical backgrounds |
| Work Environment | Office environment or remote |
| Official Job Posting | View Fortrea Regulatory Operations Specialist I Job |
2. About the Role
This position covers more than routine regulatory documentation. According to the job description, the role involves laboratory equipment, qualification and validation, cGMP documentation, computerized systems, quality processes and pharmaceutical product lifecycle activities.
The professional will also support activities involving import/export licences, Dual Use NOCs and Import Certificates, along with trackers, metrics and quality checks.
For readers interested in building a career in Regulatory Affairs after pharmacy, see our guide on Career in Regulatory Affairs After B.Pharm.
3. Key Responsibilities
The main responsibilities mentioned in the Fortrea posting include:
| Area | Responsibilities |
|---|---|
| Laboratory Instruments | Manage installation, qualification and maintenance activities |
| Qualification & Validation | Support qualification of instruments and software |
| Documentation | Prepare or review SOPs, protocols, VMPs and other cGMP documents |
| Quality Systems | Handle nonconformance reports, change controls and CAPA |
| Computerized Systems | Conduct data integrity assessments |
| Compliance | Evaluate instrument specifications against USP/EP requirements |
| Audits | Support internal and external audits |
| Regulatory Operations | Maintain trackers, metrics and quality checks |
| Import/Export Activities | Work with licences, Dual Use NOCs and Import Certificates |
| Product Lifecycle | Support development and post-approval activities |
| Training | Assist with onboarding, training and mentoring |
The role also includes supporting digital transformation initiatives related to equipment lifecycle management, eCMMS assets and preventive maintenance schedules.
4. Eligibility and Experience
Fortrea has listed multiple educational routes for this position.
Educational Background
The job posting mentions candidates with backgrounds such as:
- Bachelor’s degree in Pharmacy or a related science field
- Advanced degree with relevant experience
- Bachelor’s degree in Engineering/B.Tech
- Packaging, Polymer or Printing
- Relevant postgraduate qualification, diploma or certification in packaging
Candidates from technical or packaging backgrounds should also have experience relevant to the area specified in the posting.
Experience
The posting mentions 4–7 years of experience in the relevant job discipline. Relevant areas include Regulatory Affairs, Quality Assurance, analytical science, pharmaceutics, packaging, material management, drug development and manufacturing.
The qualification section also describes a 2–4 year experience route for certain educational backgrounds, while the preferred experience section mentions 4–7 years. Candidates should compare their own qualifications and experience with the complete official posting.
5. Skills and Knowledge
The role requires both technical knowledge and the ability to manage documentation and cross-functional work.
| Skill / Knowledge | Details |
|---|---|
| Regulatory Knowledge | Pharmaceutical regulatory requirements |
| GxP / ICH-GCP | Knowledge is desirable |
| Documentation | SOPs, protocols, VMPs and quality records |
| Data Management | Electronic document and data management |
| RIM Systems | Knowledge preferred |
| Data Integrity | Assessment of computerized systems |
| Analytical Skills | Identifying process gaps and root causes |
| Communication | Working with internal teams and clients |
| Organization | Managing priorities and deadlines |
| Microsoft Office | Office and documentation tools |
A Regulatory Affairs diploma or certification is also listed as a preferred qualification.
6. What Makes This Role Different?
The position brings together several areas that are often handled separately in pharmaceutical organizations.
For example, the responsibilities move from laboratory equipment qualification and validation to quality systems, regulatory documentation, data integrity and product lifecycle support. It also includes specific import/export regulatory activities.
For an experienced professional, this means the position is not limited to preparing regulatory documents. The work involves coordination between regulatory, quality, laboratory and operational activities.
7. How to Apply
Candidates who meet the requirements can review the complete job description and apply through Fortrea’s official careers website.
Official Job Posting:
Fortrea Regulatory Operations Specialist I – Job ID 265581
Official Fortrea Careers:
Fortrea Careers
Before applying, check the official posting for the latest eligibility requirements, vacancy status and application instructions.
8. Important Note for Candidates
This is an experienced-level position, so having a relevant degree alone may not be enough. Candidates should compare their professional experience with the responsibilities and experience requirements mentioned in the official posting.
Use the official Fortrea careers website for the application and verify the job details before submitting your application.
9. Frequently Asked Questions
Is B.Pharm eligible for the Fortrea Regulatory Operations Specialist I role?
Yes. A Bachelor’s degree in Pharmacy or a related science field is included among the listed qualifications. Relevant professional experience is also required.
Is this a fresher job?
No. The posting specifies relevant professional experience, with 4–7 years mentioned in the experience requirements.
Where is the position located?
The position is listed in Mumbai, Maharashtra, under Job ID 265581.
Which backgrounds may be relevant?
The posting mentions areas including Regulatory Affairs, Quality Assurance, analytical science, pharmaceutics, packaging, material management, drug development and manufacturing.
What is the main focus of the role?
The position combines regulatory operations, quality systems, laboratory equipment lifecycle management, validation, cGMP documentation and product lifecycle activities.
Related Articles
- Career in Regulatory Affairs After B.Pharm
- Career in Quality Assurance (QA) After B.Pharm
- Genpact Regulatory Affairs Job in Mumbai
Final Thoughts
The Fortrea Regulatory Operations Specialist I role may suit experienced professionals from B.Pharm, Regulatory Affairs, QA and related backgrounds. Candidates should review the experience requirements and official job posting before applying.
