Regulatory Operations Assistant I – Fortrea
Location
Mumbai, India
Job Type
Full-time
Experience Required
0–1 year of experience in Regulatory Affairs, Quality Assurance, Medical Devices, Pharmaceutical Development, Analytical Science, Formulation Science, Material Management, or related healthcare/pharmaceutical fields.
Fresh graduates with relevant educational backgrounds are encouraged to apply.
Estimated Salary Package (Market Standard)
₹4.8 – ₹7.5 LPA (approx.), based on qualifications, skills, and interview performance.
Job Overview
The Regulatory Operations Assistant I supports Quality Risk Management (QRM) activities for combination products by assisting with risk assessments, technical documentation, compliance reviews, and CAPA initiatives. The role involves collaborating with cross-functional teams to ensure product quality, regulatory compliance, and continuous improvement throughout the product lifecycle.
Key Responsibilities
Support the implementation of Quality Risk Management (QRM) processes, procedures, and documentation.
Assist in risk management activities for combination products used in surgical procedures.
Provide quality support during new combination product development and lifecycle management.
Prepare technical reports in compliance with cGMP requirements.
Collaborate with stakeholders to identify process improvements and support project objectives.
Participate in meetings and calls, including US business hours when required.
Assist in data-driven risk assessments, risk analysis, evaluation, and CAPA planning.
Perform assigned tasks according to Standard Operating Procedures (SOPs).
Maintain and coordinate documentation within document management systems.
Ensure compliance with internal procedures and customer requirements.
Support troubleshooting of documentation-related issues and coordinate timely resolution.
Educational Qualification
Bachelor's degree in Engineering, Life Sciences, Health Sciences, Pharmacy, or a related discipline.
Master's degree or PhD in a relevant field is also acceptable.
Equivalent relevant experience may be considered in place of formal educational qualifications.
Required Skills
Basic understanding of the pharmaceutical product lifecycle.
Knowledge of cGMP, GxP, and ICH-GCP guidelines.
Proficiency in Microsoft Office applications.
Familiarity with document management or publishing tools.
Strong analytical and problem-solving abilities.
Excellent organizational and time management skills.
Good interpersonal and communication skills.
Attention to detail with a quality-focused mindset.
Proactive attitude, accountability, and ownership of assigned tasks.
Customer-focused approach.
Preferred Qualifications
Bachelor's degree in Pharmacy or a related science discipline.
Diploma or Certification in Regulatory Affairs.
Knowledge of Management Information Systems (MIS).
Familiarity with Regulatory Information Management (RIM) or other electronic data management systems.
Understanding of surgical procedures and combination products is an advantage.
Work Environment
Office-based or remote work environment.
No special physical demands.
Flexibility to attend meetings during US business hours when required.
Who Should Apply
Freshers and early-career professionals interested in Regulatory Affairs, Quality Assurance, Medical Devices, Pharmaceutical Operations, or Combination Products.
Candidates seeking a career in Quality Risk Management and global regulatory operations within the pharmaceutical and healthcare industry.
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