Life Science Jobs: Fortrea is Hiring a Regulatory Operations Expert | Apply Now
Searching for high-impact life science jobs in India? Fortrea is hiring a Regulatory Operations Expert in Mumbai an exciting opportunity for professionals who want to grow a long-term Fortrea career while contributing to major global submissions. If you’re skilled in regulatory processes and passionate about impactful biological science jobs, this role places you at the center of global health authority documentation and regulatory strategy.
Job Details:
- Job Title: Regulatory Operations Expert
- Locations: Mumbai
- Time Type: Full time
- Job Requisition ID: 255415
About the Company
Fortrea is a leading global Clinical Research Organization (CRO) delivering innovative solutions across clinical development, regulatory operations, and scientific consulting. Known for its strong global footprint and deep scientific expertise, Fortrea supports top pharmaceutical, biotechnology, and life-science companies in bringing safer, high-quality products to market.
For professionals seeking life science jobs or growth-focused biological science jobs, Fortrea offers an environment that blends scientific excellence with global exposure. The company provides end-to-end support across regulatory submissions, quality systems, and compliance—making it an ideal place to build a long-term and impactful Fortrea career. With a culture rooted in innovation, collaboration, and patient-centric outcomes, Fortrea continues to shape the future of global healthcare and regulatory operations.
Key Responsibilities
Regulatory Operations
- Manage regulatory affairs and project oversight for clients.
- Handle resource allocation, performance evaluations, and team management.
- Oversee regulatory document creation, revision, approval, and compilation.
Quality Assurance Responsibilities (JnJ Contractor Role)
- Report to the QA Laboratory group (CSQ, Product Quality Management).
- Review/approve method validation reports, protocols, qualification documents.
- Manage CAPA, Change Controls, and Quality Issue handling.
- Support quality culture improvements and KPI monitoring.
- Participate in CAPA boards, Quality Improvement meetings, and CONNECT sessions.
Educational Requirements
- Bachelor’s or Master’s degree in biological sciences, or equivalent experience.
- 3–5 years’ pharmaceutical industry experience.
Skills Required
- Experience in laboratory operations: method development, validation, stability testing, microbiology, instrument qualification, etc.
- Strong understanding of cGMP & ICH guidelines.
- Excellent communication skills (English).
- Ability to work in global, cross-cultural environments.
- Strong negotiation and influencing skills.
- Agile mindset and ability to adapt to change.
- Diversity & inclusion mindset.
This role is a strong match for professionals seeking progressive life science jobs or advanced biological science jobs in global regulatory operations. Joining Fortrea allows you to build a future-focused Fortrea career while contributing to global healthcare compliance and quality excellence. If you’re ready to step into a high-impact regulatory role, this opportunity is for you.
