Apply for Regulatory Operations Principal Specialist at Fortrea Mumbai. Check eligibility, salary, senior role details, and apply online before deadline.
Introduction
The Regulatory Operations Principal Specialist at Fortrea 2026 is a senior-level opportunity designed for experienced professionals in regulatory affairs, quality assurance, and pharmaceutical operations. This role offers leadership responsibilities, global exposure, and the chance to manage complex regulatory projects across international markets. If you have strong expertise in regulatory compliance and team management, this position can significantly elevate your career.
Job Overview
| Job Title | Regulatory Operations Principal Specialist |
|---|---|
| Company Name | Fortrea |
| Location | Mumbai, India |
| Employment Type | Full-Time |
| Department | Regulatory Affairs / Quality Operations |
| Experience Required | 7–15 Years |
| Education | B.Pharm / M.Pharm / PhD / Engineering (Packaging/Polymer/Printing) |
| Salary | As per company standards |
Company Overview
Fortrea is a globally established clinical research organization offering end-to-end solutions in drug development, regulatory affairs, and clinical trials. The company partners with pharmaceutical and biotechnology organizations to accelerate product approvals while maintaining strict regulatory compliance. With a strong focus on innovation and quality, Fortrea provides professionals with opportunities to work on international projects and develop advanced expertise in regulatory sciences.
Job Location & Employment Type
- Location: Mumbai, Maharashtra
- Employment Type: Full-Time
- Work Environment: Office-based or hybrid, depending on project requirements
Open Positions / Department Details
This role is part of the Regulatory Operations and Quality Assurance team, responsible for managing global regulatory documentation and ensuring compliance across the pharmaceutical product lifecycle. The position also involves leadership responsibilities, including team management and project coordination.
Key Roles & Responsibilities
- Lead and manage regulatory operations projects for global clients
- Oversee preparation, review, and approval of regulatory and labeling documents
- Ensure timely submission of documents to health authorities (US, EU, Japan, and other regions)
- Manage team performance, conduct reviews, and handle resource allocation
- Review investigations and provide scientific and compliance-based inputs
- Investigate deviations such as Non-Conformances, OOS, OOE, and OOT
- Prepare scientific investigation reports aligned with regulatory standards
- Develop and maintain quality dashboards, reports, and improvement plans
- Support internal and external audits and ensure audit readiness
- Coordinate training programs and ensure team compliance with SOPs
- Perform gap analysis and update standard operating procedures
- Monitor laboratory and regulatory processes for efficiency and compliance
- Identify risks, troubleshoot issues, and implement corrective actions
- Ensure high-quality service delivery to clients in a cost-effective manner
Eligibility Criteria
Education
- Bachelor’s degree in Pharmacy or Life Sciences
- OR Master’s degree / PhD in a related field
- OR Engineering degree (Packaging, Polymer, Printing) with relevant experience
- Certification in Regulatory Affairs is preferred
Experience
- 7–9 years of experience in regulatory affairs, quality assurance, or related domains
- OR up to 10–15 years of experience in pharmaceutical industry (especially QA)
- At least 1+ year of project management and team handling experience preferred
Skills Required
- Strong understanding of pharmaceutical product lifecycle
- Knowledge of global regulatory guidelines (GxP, ICH-GCP)
- Expertise in regulatory documentation and submission processes
- Proficiency in Microsoft Office and document management tools
- Leadership and team management skills
- Strong analytical and problem-solving abilities
- Excellent communication and presentation skills
- Attention to detail and data accuracy
- Ability to manage audits and compliance requirements
- Time management and ability to meet deadlines
- Adaptability and proactive approach to problem-solving
Salary & Benefits
- Salary: As per company standards
- Additional benefits may include:
- Health and insurance coverage
- Leadership and career development programs
- Global project exposure
- Training and certification support
- Flexible work environment
Selection Process
- Initial application screening
- HR discussion
- Technical/functional interview
- Managerial or leadership round
- Final selection and offer
How to Apply
Candidates can apply through the official Fortrea careers portal. Make sure your resume highlights your leadership experience, regulatory knowledge, and project management skills.
Important Dates
- Last Date to Apply: April 15, 2026
Why Apply for This Job?
- Senior-level leadership role in a reputed global CRO
- Opportunity to manage international regulatory projects
- Exposure to global compliance standards and audits
- Strong career growth in regulatory operations and quality assurance
- Chance to lead teams and influence strategic decisions
- Work in a dynamic and globally connected environment
This position is ideal for professionals aiming to transition into leadership roles within regulatory affairs and pharmaceutical operations.
FAQs
Who can apply for this job?
Experienced professionals with 7–15 years in regulatory affairs, quality assurance, or pharmaceutical operations can apply.
What is the salary range?
The salary is based on company standards and depends on experience and expertise.
Is team management experience required?
Yes, at least 1 year of project or team management experience is preferred.
How can I apply?
You can apply through the official Fortrea careers website.
What skills are essential for this role?
Leadership, regulatory knowledge, analytical thinking, communication skills, and experience in compliance and audits are essential.
Conclusion
The Regulatory Operations Principal Specialist at Fortrea 2026 is an excellent opportunity for experienced professionals seeking leadership roles in regulatory affairs. With responsibilities spanning global submissions, team management, and compliance oversight, this role offers significant career advancement and exposure to international pharmaceutical operations. Apply before the deadline to secure your chance in this high-impact role.
Disclaimer
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