Regulatory Operations Specialist I

Fortrea; Mumbai; Remote; INR 900,000 - 1,800,000; Full time

Job summary

Fortrea is seeking a seasoned Quality Assurance professional to lead regulatory operations activities for client projects, overseeing document creation, review, and compliance across US, EU, Japan, and ROW.

The role involves coordinating a team, performing risk assessments, handling CAPA and change controls, and ensuring timely delivery of high-quality regulatory submissions.

Office-based or remote work is possible, with collaboration across global stakeholders.

Qualifications

• Bachelor or Master degree in pharmaceutical/chemical/biological sciences; 5–7 years' experience in pharmaceutical industry, preferably in QA.

Responsibilities

• Review and approve documents such as protocols and reports for method qualification, validation, transfer, investigations and non-conformances.
• Handle Quality Issues, CAPAs, deviations, and Change Controls related to the client and contract laboratories.
• Collaborate with supported departments to maintain and improve quality culture and QA KPIs.
• Participate in QA meetings such as CSQ, CAPA board, Quality improvement program and business connect meetings as appropriate.
• Scope may evolve based on QA/business needs.
• Collaborate to build relationships with stakeholders to identify opportunities for improvement and to support CAPA plans.

Education

Bachelor or Master degree in Pharmaceutical, Chemical or Biological sciences (or equivalent)

Job description

Job Overview

• Perform various project management and regulatory affairs activities for Fortrea clients. Manage team including performance reviews, human resource issues, and assist Senior Management in assigning resources to projects as required. Manage, coordinate and oversee the overall Regulatory Operations associated with creation/revision/compilation/approval of specifications, regulatory and labeling documents across the product lifecycle for submission by Fortrea clients to US, EU, Japan, and ROW health authorities within the agreed/stated timelines, as applicable. The post holder is responsible for supporting team members in providing this service to clients either as a support function to the client project groups or as stand-alone business. Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.

Summary Of Responsibilities

• Review and approval of documents such as but not limited to protocols and report for Method qualification, method validation, transfer; and investigations and non-conformances
• Handling of Quality Issues, Corrective/Preventive Actions, and Change Controls related to the client as well as their contract laboratories
• Works with the supported departments to maintain and continuously improve the quality culture to positively influence Quality KPI.
• Actively participates in meetings such as Quality Assurance (QA) CSQ meetings, Capa board, Quality improvement program and business connect meetings as appropriate.
• Scope may evolve based on QA/business needs
• Collaborate and build trusting relationships with all stakeholders and business partners in identifying opportunities for improvement and meeting goals and objectives.
• Collaborate on data driven risk assessments (risk identification, analysis and evaluation) and formulate risk mitigation plans as well as support Corrective and Preventive Action (CAPA) plan initiatives.
• Be accountable to ensure quality & compliance with procedures and customer requirements.
• Identify potential issues, perform trouble shooting, resolve conflicts and provide solutions as applicable.

Qualifications (Minimum Required)

• Bachelor or Master degree, scientific oriented (pharmaceutical, chemical or biological sciences) or equivalent by experience with at least 5-7 years' experience in pharmaceutical industry preferably in the Quality assurance department

Physical Demands/Work Environment

• Physical demands: No special factor at this time.
• Work environment: Office environment or remote.

Learn more about our EEO & Accommodations request here.