Fortrea Hiring Regulatory Operations Associate II
Fortrea, a global contract research organization (CRO), has opened applications for the role of Regulatory Operations Associate II at its Mumbai location. This position offers a golden opportunity for experienced professionals in Regulatory Affairs, CMC documentation, and Quality Compliance to contribute to one of the most dynamic teams in the pharmaceutical sector. Fortrea Hiring Regulatory Operations Associate II
In this detailed article, we provide comprehensive information about the role, required qualifications, responsibilities, benefits, and how to apply for the post before the application deadline.
About Fortrea
Fortrea is a leading global CRO dedicated to delivering innovative, science-driven solutions to pharmaceutical, biotechnology, and medical device companies. Fortrea specializes in clinical trial management, regulatory submissions, safety services, and patient-centric data analytics. With a strong focus on regulatory compliance and scientific integrity, Fortrea ensures life-saving therapies are brought to market safely and efficiently. Fortrea Hiring Regulatory Operations Associate II
Operating in more than 60 countries, Fortrea continues to be a trusted partner for organizations that require end-to-end drug development support.
Job Overview
- Position Title: Regulatory Operations Associate II
- Company: Fortrea
- Location: Mumbai, Maharashtra
- Job Type: Full-Time (Office-Based)
- Experience Required: 2 to 5 Years
- Application Deadline: July 21, 2025
- Job ID: 252255
Key Responsibilities
The Regulatory Operations Associate II will be involved in end-to-end preparation and management of Chemistry, Manufacturing, and Controls (CMC) documentation as well as global regulatory submissions. Key responsibilities include:
1. CMC & Regulatory Document Preparation
- Prepare, compile, and review CMC documentation in accordance with regional and international regulatory requirements.
- Ensure quality, completeness, and compliance of regulatory submissions for global health authorities (e.g., USFDA, EMA).
2. Data Management & Documentation
- Manage and maintain raw material specifications, packaging components, and change control documentation.
- Evaluate stability data, dissolution profiles, and support related studies for regulatory filings.
3. Cross-Functional Coordination
- Work closely with regulatory, analytical, packaging, QA/QC, and supply chain teams to align submission data and timelines.
- Coordinate supplier data collection, validation, and risk assessment processes.
4. Regulatory Compliance Support
- Participate in Global Triage meetings, review global labeling changes, and ensure adherence to ICH, GxP, and local regulations.
- Support Computerized System Validation (CSV) documentation and periodic regulatory updates.
5. Training & Team Support
- Provide onboarding and functional training to new associates in regulatory documentation procedures.
- Support internal process improvements and quality check initiatives.
Eligibility Criteria
Minimum Educational Qualifications
- Bachelor’s degree in Pharmacy, Science, or Engineering (B.Tech in Packaging, Printing, or Polymer disciplines acceptable).
Minimum Work Experience
- 2 to 5 years of hands-on experience in Regulatory Affairs, Quality Assurance, or Analytical Development within the pharmaceutical or life sciences domain.
Technical Skills Required
- Proficiency in Microsoft Office Suite and document management tools such as Veeva Vault, eCTD, or RIM systems.
- Strong understanding of regulatory pathways, dossier formats, and submission procedures.
- Capability to interpret and manage technical documents, SOPs, and change control records.
Preferred Qualifications
- Master’s degree or PhD in Regulatory Affairs, Pharmaceutical Sciences, or related fields.
- Additional Diploma/Certification in Regulatory Affairs or Packaging Technology is a plus.
- Familiarity with Regulatory Information Management (RIM) systems or e-submission platforms.
Required Soft Skills
- Excellent written and verbal communication skills in English.
- Strong analytical mindset, attention to detail, and documentation discipline.
- Organizational efficiency and ability to handle multiple regulatory projects simultaneously.
Benefits & Work Environment
Fortrea offers a progressive work culture with a focus on innovation, compliance, and professional development. Employees working in the Mumbai office enjoy: Fortrea Hiring Regulatory Operations Associate II
- A collaborative work culture with access to international teams and industry experts.
- Continuous learning opportunities through internal training and mentorship programs.
- Career development pathways across regulatory operations and quality systems.
- Direct exposure to global pharmaceutical lifecycle management and submission planning.
Why Choose a Career in Regulatory Affairs at Fortrea?
Joining Fortrea as a Regulatory Operations Associate II allows professionals to work at the intersection of science, technology, and regulatory strategy. This role not only enhances your understanding of global regulatory systems but also positions you as a valuable asset in ensuring the safety and efficacy of medicines brought to market. Fortrea Hiring Regulatory Operations Associate II
Fortrea’s global reach, compliance-first approach, and industry credibility make it a top employer for those passionate about drug development, documentation excellence, and regulatory science.
How to Apply
Candidates interested in applying should ensure they meet the eligibility and experience criteria. To apply:
- Visit the official careers page of Fortrea or trusted job portals.
- Search for Job ID: 252255.
- Submit your updated resume along with a cover letter (optional but recommended).
- Ensure your application is submitted before July 21, 2025.
Early applications are encouraged due to the limited vacancy window.
Final Thoughts
This opening for Regulatory Operations Associate II in Mumbai is a rare opportunity to work with a leading CRO that values regulatory compliance, innovation, and global standards. Whether your background is in pharmacy, packaging, or life sciences, if you have the required experience and a passion for regulatory documentation, this role at Fortrea could be the next milestone in your career. Fortrea Hiring Regulatory Operations Associate II
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