Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance

Regulatory Operations Assistant I – Fortrea Discover more

Sciences

Health Foundations & Medical Research career

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 Discover more

Educational

Trainings job pharmaceutical

Vocational & Continuing Education educational 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.
- Valuable 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.

Regulatory Operations Assistant I – Fortrea Discover more

Sciences

Health Foundations & Medical Research career

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.

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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