Regulatory Operations Specialist I

Job Overview:
Responsible for responsible for managing laboratory instruments, ensuring compliance with regulatory standards, and supporting quality and validation activities in a cGMP environment.
Summary of Responsibilities:
Manage the entire lifecycle of laboratory instruments, including installation, qualification, and maintenance.
Oversee the qualification process of new instruments and software, ensuring compliance with internal and external standards.
Prepare and review SOPs, protocols, validation master plans, and other cGMP documentation.
Handle nonconformance reports, initiate change controls, and implement corrective and preventive actions.
Assist in driving digital transformation initiatives within equipment lifecycle management activities
Maintain and update relevant documentation such as VMP, MMP, eCMMS Assets, and Preventive Maintenance schedules.
Conduct data integrity assessments of computerized systems.
Evaluate instrument specifications against USP/EP standards for compliance.
Assist in implementing systems that meet applicable regulatory requirements.
Issue laboratory notebooks and coordinate timely reviews of SOPs and WI.
Support internal and external audits for the department.
Provide support to ECLs in all activities related to equipment lifecycle management.
Escalate the potential issues and serve as analytical strategist and coordinator across the product development stages and post approval maintenance, as applicable.
Management, review and submission of Import/Export Licenses, Dual Use NOC’s and Import Certificates. Responsible for license applications, license availability, debiting and reconciliation, as applicable.
Seek guidance from other team members and manager as needed and keep up to date knowledge of various regulatory guidelines required for pharmaceutical product registration and product life cycle maintenance.
Implement the use of consistent, efficient and quality processes to meet timelines and deliverables according to regulatory requirements, standard operating procedures and maintain a culture of high customer services.
Update and maintain internal and external (client) trackers for metrics, perform and document quality checks, as applicable.
Assist in onboarding, training and mentoring junior staff and perform additional duties as assigned by the manager.
Maintain training related documentation as per Fortrea and client requirements.
Qualifications (Minimum Required):
Bachelor’s in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD or Masters) with experience of 2-4 years. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR
Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream or Packaging Postgraduate/Diploma/Certification in Packaging with minimum 2-4 years of experience in Packaging field will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”
Speaking-English and/or other languages as applicable.
Experience (Minimum Required):
At least 4-7 Years of experience in the job discipline (e.g. Regulatory Affairs/ Quality Assurance/Analytical science / Packaging, polymer and/or printing stream / pharmaceutics / material management and overall drug development and manufacturing process).
Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools.
Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable.
Good organizational and time management ability.
Good analytical capabilities and Customer focus.
Good review skills and concern for quality..
Preferred Qualifications Include:
Bachelor’s in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD or Masters) with experience of 4-7 years. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR
Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream or Packaging Postgraduate/Diploma/Certification with minimum 4-7 years of experience in packaging field will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”
Knowledge of Management Information System (MIS) and electronic data management system (eg: Regulatory Information Management, etc.) system will be preferred.
Diploma or certification in Regulatory Affairs will be preferred.
Interpersonal skills, Problem solving, Innovation and Proactive, taking ownership, Precise, Goal oriented.
Leadership, problem solving, interpersonal skills.
Excellent analytical skills with the ability to identify process gaps and root causes and develop innovative solutions.
Ability to work independently, meet tight deadlines, and maintain a positive attitude.
Physical Demands/Work Environment:
Physical demands: No special factor at this time.
Work environment: Office environment or remote.
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