Regulatory Operations Expert Job in Mumbai at Fortrea. Senior regulatory affairs job for experienced pharma professionals with global submission experience in India.
Fortrea is inviting applications for the role of Regulatory Operations Expert at its Mumbai location. This is a full-time opportunity for experienced regulatory affairs and quality professionals who want to work in a global clinical and regulatory environment. The role involves managing regulatory documentation, overseeing regulatory operations, and leading teams supporting global submissions.
If you have experience in regulatory affairs, quality assurance, or pharmaceutical lifecycle management, this role offers an excellent opportunity to work with international clients and health authorities. Regulatory Operations Expert Job in Mumbai at Fortrea
Company Overview
Fortrea is a global contract research organization (CRO) focused on supporting pharmaceutical and biotechnology companies across clinical development, regulatory services, and lifecycle management. The company collaborates with global healthcare innovators to streamline clinical trials and regulatory processes.
With operations across multiple regions, Fortrea provides specialized services in regulatory affairs, clinical operations, and data-driven development strategies. Professionals working at Fortrea gain exposure to international regulatory frameworks and cross-functional global teams. Regulatory Operations Expert Job in Mumbai at Fortrea
Job Location & Employment Type
- Job Title: Regulatory Operations Expert
- Company: Fortrea
- Location: Mumbai, Maharashtra, India
- Employment Type: Full-Time
- Work Mode: Onsite (Client location)
- Application Deadline: 22 February 2026
This position involves working from a client facility in Mumbai and may include limited travel requirements.
Department Details
The Regulatory Operations Expert role sits within the regulatory affairs and quality function, supporting documentation, compliance, and submission processes for global markets. The position involves close coordination with project teams handling regulatory submissions across regions such as the US, EU, Japan, and Rest of World (ROW). Regulatory Operations Expert Job in Mumbai at Fortrea
The selected candidate will play a key role in managing regulatory documentation, quality compliance activities, and team coordination across multiple projects. Regulatory Operations Expert Job in Mumbai at Fortrea
Key Roles & Responsibilities
As a Regulatory Operations Expert, you will be responsible for managing regulatory workflows and ensuring compliance across the product lifecycle. Key responsibilities include: Regulatory Operations Expert Job in Mumbai at Fortrea
- Managing regulatory operations including creation, revision, and compilation of submission documents
- Supporting global submissions to regulatory authorities across multiple regions
- Reviewing and approving regulatory and quality documents
- Writing and reviewing scientific investigation reports
- Handling non-conformance investigations including OOS, OOE, and OOT cases
- Preparing quality dashboards and performance metrics
- Supporting internal audits and compliance reviews
- Coordinating training processes and documentation workflows
- Managing SOP gap assessments and revisions
- Supporting laboratory process documentation and quality systems
- Identifying operational challenges and implementing solutions
- Ensuring timely delivery of regulatory documentation
- Collaborating with global teams and stakeholders
- Mentoring team members and supporting performance development
- Assisting senior management with project planning and resource allocation
This role requires both technical regulatory expertise and strong project management capabilities. Regulatory Operations Expert Job in Mumbai at Fortrea
Eligibility Criteria
Education
Candidates must have one of the following qualifications:
- Bachelor’s or Master’s degree in:
- Pharmacy
- Pharmaceutical Sciences
- Chemistry or Biology
- Life Sciences
Alternative backgrounds may also be considered, including:
- Engineering or Packaging-related degrees
- Polymer or printing science qualifications
- Equivalent professional experience in regulatory or quality roles
Certifications in regulatory affairs are considered an added advantage.
Experience
Experience requirements vary depending on role level:
- Minimum 3–5 years of pharmaceutical industry experience (basic requirement)
- Preferred:
- 10–13 years of experience in Regulatory Affairs, Quality Assurance, or related domains
- At least 5 years of project or people management experience
Candidates with exposure to end-to-end drug development processes will be highly preferred. Regulatory Operations Expert Job in Mumbai at Fortrea
Skills Required
Applicants should demonstrate the following competencies:
- Strong knowledge of cGMP and ICH guidelines
- Experience with regulatory documentation and lifecycle management
- Familiarity with laboratory environments and quality systems
- Ability to manage global regulatory submissions
- Strong analytical and problem-solving skills
- Excellent written and verbal communication in English
- Proficiency in MS Office tools
- Ability to work in cross-functional global teams
- Leadership and mentoring abilities
- Strong attention to detail and data accuracy
- Experience handling audits and inspections
- Adaptability and ability to work in evolving regulatory environments
Knowledge of regulatory platforms, data management systems, or MIS tools is advantageous. Regulatory Operations Expert Job in Mumbai at Fortrea
Salary & Benefits
- Compensation will be offered as per company norms
- Additional benefits may include:
- Exposure to global regulatory projects
- Leadership and management opportunities
- Career growth within a multinational CRO
- Professional development and training programs
- Collaborative international work environment
Exact compensation details are not disclosed.
Selection Process
The hiring process generally includes:
- Online application submission
- Profile shortlisting
- Technical interviews (Regulatory/QA focus)
- Managerial or leadership interview
- Final HR round and offer
Senior candidates may undergo multiple evaluation rounds.
How to Apply
Interested candidates should apply through the official Fortrea careers portal before the deadline.
Ensure your resume highlights:
- Regulatory submissions experience
- Quality and compliance exposure
- Project management achievements
- Global regulatory knowledge
Applying early is recommended due to the limited application window.
Important Dates
- Application Deadline: 22 February 2026
Candidates should apply before the closing date to avoid missing this opportunity.
Why Apply for This Pharma Job?
This role offers strong advantages for experienced regulatory professionals:
- Opportunity to work with a global CRO
- Exposure to international regulatory frameworks
- Leadership and team management responsibilities
- Involvement in full product lifecycle regulatory operations
- Growth opportunities in regulatory strategy and compliance
- High-value experience in global submissions
If you are aiming for senior growth in regulatory affairs or quality operations, this role provides significant career advancement potential. Regulatory Operations Expert Job in Mumbai at Fortrea
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that publishes pharmaceutical and healthcare job updates for informational purposes only. We are not affiliated with Fortrea or any organization mentioned in this post. Candidates should verify all details through official company channels before applying. Regulatory Operations Expert Job in Mumbai at Fortrea
Final Words
Senior regulatory roles in global CROs are highly competitive and offer strong long-term career growth. If you have experience in regulatory operations, quality systems, and global submissions, this Fortrea opportunity could be a valuable step forward. Prepare a strong, achievement-focused resume and apply before the deadline to maximize your chances.
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