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Regulatory Operations Assistant I

MUMBAI (IN)ONSITEPOSTED: 7/15/2026
PHARMAFull-time
HIRING ORGANIZATIONFORTREAContract Research Organization (CRO) / Biosciences / Healthcare
Fortrea

ROLE DEFINITION & RESPONSIBILITIES

Fortrea is currently hiring for the position of Regulatory Operations Assistant I in Mumbai, India. This opportunity is ideal for B.Pharm, M.Pharm, and Life Sciences graduates who want to build a career in Regulatory Affairs, Regulatory Operations, and pharmaceutical documentation management.

Key Responsibilities

Preparation, compilation, revision, and approval of regulatory submission documents.
Supporting submissions to US FDA, EMA (EU), Japan PMDA, and other global health authorities.
Maintaining regulatory documentation and specifications.
Ensuring compliance with GMP, GLP, GDP, cGMP and ICH guidelines.
Supporting analytical testing documentation and quality review.
Managing electronic document management systems (EDMS).
Maintaining training documentation and regulatory records.
Coordinating regulatory submission activities across teams.

Qualifications

B.Pharm, M.Pharm, or Life Sciences degree.
0-3 years of experience in regulatory affairs, analytical science, QA, or drug development.

Skills Required

Understanding of pharmaceutical product lifecycle.
Knowledge of GxP and ICH-GCP guidelines.
Strong documentation and review skills.
Proficiency in Microsoft Office tools.

REQUIRED VERIFIED SKILLS

Regulatory Affairs
Pharmaceutical Documentation
GxP
ICH Guidelines
MS Office

COMPENSATION & REWARDS

₹4.0L - 7.0L per annum
The estimated salary range of 4-7 LPA reflects competitive industry standards for regulatory operations roles in Mumbai, accounting for variations in academic qualifications and prior relevant experience.

ORGANIZATION CONTEXT & CULTURE

Fortrea is a global contract research organization (CRO) providing comprehensive clinical development, patient access, and laboratory services. Spun off from Labcorp in 2023, Fortrea partners with pharmaceutical, biotech, and medical device companies to accelerate the development and commercialization of new therapies. They offer a full suite of services across the entire drug development lifecycle.

TEAM SIZE: 19,000+ employees
INDUSTRY: Contract Research Organization (CRO) / Biosciences / Healthcare

EXPECTED CAREER ROADMAP

Fortrea provides exposure to global regulatory submissions across US, EU, Japan, and ROW markets. This role serves as a foundational step for long-term career growth into senior regulatory affairs, quality assurance, or project management positions within global clinical research organizations.

APPLICATION ADVISORY

Highlight your understanding of the drug development lifecycle and any familiarity with electronic document management systems. Be prepared to discuss your knowledge of regulatory submission processes and your attention to detail regarding compliance documentation.
RECOMMENDED TRAINING
1/5
Biologics Regulatory Affairs Certification

Biologics Regulatory Affairs Certification

READY TO SUBMIT?

Verify your capability profile and matching credentials before submitting direct applications.