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 domains.
Fresh graduates with relevant academic background may also be considered.
Estimated Salary Package (Market Standard)
₹4.5 – ₹7 LPA (approx.), depending on qualifications, skills, and interview performance.
Job Overview
The Regulatory Operations Assistant I supports Quality Risk Management activities for combination products by assisting with risk assessments, technical documentation, compliance reviews, and CAPA initiatives. The role involves working with cross-functional teams to ensure regulatory compliance, product quality, 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 product development and lifecycle management.
Prepare technical reports in compliance with cGMP requirements.
Collaborate with internal stakeholders to achieve project goals and identify process improvements.
Participate in meetings and calls, including those during US business hours when required.
Contribute to risk identification, analysis, evaluation, and development of risk mitigation and CAPA plans.
Perform assigned tasks in accordance with Standard Operating Procedures (SOPs).
Maintain and coordinate documentation within document management systems.
Ensure compliance with internal procedures and customer requirements.
Assist in troubleshooting documentation-related issues and support timely resolution.
Educational Qualification
Bachelor's degree in Engineering, Life Sciences, Health Sciences, Pharmacy, or a related field.
Master's degree or PhD in a relevant discipline is also acceptable.
Equivalent relevant experience may be considered in place of educational qualifications.
Required Skills
Basic understanding of pharmaceutical product lifecycle.
Knowledge of GxP, cGMP, and ICH-GCP guidelines (preferred).
Proficiency in Microsoft Office applications.
Familiarity with document management and publishing tools.
Strong analytical and problem-solving abilities.
Good organizational and time management skills.
Attention to detail and quality-focused approach.
Excellent interpersonal and communication skills.
Proactive attitude with strong ownership and accountability.
Customer-focused mindset.
Preferred Qualifications
Bachelor's degree in Pharmacy or related science.
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 added advantage.
Work Environment
Office-based or remote working environment.
No special physical requirements.
Flexibility to attend meetings during US business hours when necessary.
Who Should Apply
Freshers and early-career professionals interested in Regulatory Affairs, Quality Assurance, Pharmaceutical Operations, Medical Devices, or Combination Products.
Candidates looking to build a career in Quality Risk Management and global regulatory operations within the pharmaceutical and healthcare industry.
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