Regulatory Operations Assistant Freshers Job at Fortrea in Mumbai for B.Pharm and life sciences graduates with 0–3 years regulatory experience.
The regulatory affairs sector plays a critical role in the pharmaceutical industry by ensuring that medicines meet global regulatory standards before reaching patients. Fortrea, a global clinical research organization, has announced an opportunity for the role of Regulatory Operations Assistant I at its Mumbai location.
This position is suitable for candidates who want to develop a career in regulatory affairs, pharmaceutical documentation, and drug development processes. The role involves supporting regulatory documentation and submission activities for pharmaceutical products intended for global health authorities such as the United States, Europe, Japan, and other international markets.
Fresh graduates and candidates with limited experience in regulatory affairs, quality assurance, or pharmaceutical sciences are encouraged to apply. Regulatory Operations Assistant Freshers Job at Fortrea
Company Overview
Fortrea is a global contract research organization that provides clinical development services to pharmaceutical, biotechnology, and medical device companies. The organization supports multiple stages of drug development including clinical trials, regulatory submissions, and patient-focused research programs.
With operations across nearly 100 countries, Fortrea works with healthcare companies to accelerate the development and approval of new medicines. The company provides scientific expertise, clinical research solutions, and regulatory support to ensure compliance with international healthcare regulations.
By combining advanced technology, experienced professionals, and global research capabilities, Fortrea helps pharmaceutical organizations navigate complex regulatory processes and deliver innovative treatments to patients worldwide. Regulatory Operations Assistant Freshers Job at Fortrea
Job Location & Employment Type
Company: Fortrea
Position: Regulatory Operations Assistant I
Location: Mumbai, India
Employment Type: Full-time
Work Environment: Office-based or remote depending on project requirements
Application Deadline: March 7, 2026
Open Positions / Department Details
Fortrea is hiring Regulatory Operations Assistant I professionals to support regulatory documentation and compliance activities.
The selected candidate will assist in preparing and managing regulatory documents that are submitted to international health authorities. The role involves collaboration with regulatory teams and ensuring documentation meets global regulatory requirements.
This position provides exposure to the regulatory processes involved in pharmaceutical product development and approval. Regulatory Operations Assistant Freshers Job at Fortrea
Key Roles & Responsibilities
Candidates selected for the Regulatory Operations Assistant role will be responsible for supporting regulatory documentation and compliance tasks. Regulatory Operations Assistant Freshers Job at Fortrea
Key responsibilities include:
- Preparing, compiling, and updating regulatory documents and specifications required for submission to global health authorities
- Supporting documentation related to regulatory submissions for markets such as the US, Europe, Japan, and other regions
- Ensuring adherence to Good Manufacturing Practices (GMP) and workplace safety standards
- Supporting compliance with Good Laboratory Practices (GLP) and Good Documentation Practices (GDP)
- Assisting with documentation related to pharmaceutical product development and manufacturing processes
- Maintaining training records and regulatory documentation according to company and client requirements
- Supporting analytical activities such as evaluation of pharmaceutical product testing results when required
- Ensuring documentation accuracy and regulatory compliance
- Collaborating with team members to complete regulatory documentation tasks within project timelines
- Assisting in onboarding and training of new team members when necessary
- Performing additional tasks assigned by supervisors or department heads
The role requires strong documentation skills and attention to regulatory compliance standards. Regulatory Operations Assistant Freshers Job at Fortrea
Eligibility Criteria Regulatory Operations Assistant Freshers Job at Fortrea
Candidates interested in applying should meet the following eligibility requirements.
Education
Applicants should have completed:
- Bachelor’s degree in Pharmacy (B.Pharm)
or - Bachelor’s degree in Life Sciences or related scientific discipline
Advanced degrees such as M.Pharm, MSc, or PhD in relevant fields may also be considered.
Experience
- 0–3 years of experience in pharmaceutical or regulatory-related roles
- Fresh graduates may also be considered depending on qualifications and skill sets
- Experience in regulatory affairs, quality assurance, analytical sciences, pharmaceutics, or drug development processes may be beneficial
Skills Required
Applicants should possess the following professional skills:
- Basic understanding of the pharmaceutical product life cycle
- Knowledge of GxP guidelines and ICH regulatory standards
- Familiarity with regulatory documentation processes
- Proficiency in Microsoft Office applications
- Strong organizational and documentation skills
- Ability to manage multiple tasks efficiently
- Good communication and teamwork abilities
- Strong analytical thinking and problem-solving skills
- Attention to detail and commitment to quality standards
Knowledge of regulatory information systems or electronic document management systems may be advantageous.
Preferred Qualifications
Candidates with the following additional qualifications may have an advantage:
- Certification or diploma in Regulatory Affairs
- Knowledge of Management Information Systems (MIS)
- Experience with Regulatory Information Management (RIM) systems or electronic document management platforms
- Understanding of pharmaceutical regulatory submission processes
Salary & Benefits
Compensation for this position will be provided as per company norms and may depend on qualifications, experience, and company policies. Regulatory Operations Assistant Freshers Job at Fortrea
Working with Fortrea may provide several benefits, including:
- Opportunity to work with a global clinical research organization
- Exposure to international regulatory submission processes
- Professional training and career development opportunities
- Experience working with global pharmaceutical clients
- Career growth in regulatory affairs and clinical research sectors
Selection Process
The recruitment process may involve the following stages:
- Online application submission
- Resume screening by the recruitment team
- Shortlisting of suitable candidates
- Technical or functional interview
- HR interview
- Final selection based on overall performance and suitability for the role
Shortlisted candidates will be contacted by the company for further communication. Regulatory Operations Assistant Freshers Job at Fortrea
How to Apply
Interested candidates can apply for the Regulatory Operations Assistant I position through the Fortrea careers portal by submitting their application online.
Applicants should ensure their application includes:
- Updated resume or CV
- Educational qualification details
- Relevant experience or internship details
- Contact information
Candidates are advised to apply before the application deadline. Regulatory Operations Assistant Freshers Job at Fortrea
Important Dates
Application Deadline: March 7, 2026
As the deadline is close, interested candidates should submit their applications immediately.
Why Apply for This Pharma Job?
This role provides a valuable opportunity for candidates interested in regulatory affairs and pharmaceutical compliance.
Benefits of this opportunity include:
- Entry into the regulatory affairs field within the pharmaceutical industry
- Exposure to global drug submission processes
- Opportunity to work with experienced regulatory professionals
- Development of documentation and compliance management skills
- Career growth potential in regulatory operations and pharmaceutical development
For candidates interested in regulatory sciences, this role can provide a strong foundation for long-term career advancement. Regulatory Operations Assistant Freshers Job at Fortrea
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares pharmaceutical and clinical research job updates for informational purposes only.
We are not affiliated with Fortrea or its recruitment process. Candidates are advised to verify job details directly through the company’s official website before applying. IndiaPharmaJobs.in does not charge any fee for job listings or applications. Regulatory Operations Assistant Freshers Job at Fortrea
Final Call-to-Action
If you are interested in building a career in regulatory affairs and pharmaceutical compliance, this opportunity at Fortrea could be an excellent step forward. Candidates who meet the eligibility criteria should submit their applications through the official portal before the deadline to increase their chances of selection. Regulatory Operations Assistant Freshers Job at Fortrea
