Fortrea is recruiting for the position of Regulatory Operations Specialist I in Mumbai. This is a full-time opportunity for candidates with a scientific educational background and 5–7 years of pharmaceutical industry experience, preferably in Quality Assurance.

The role involves regulatory operations, quality documentation, compliance management, risk assessment, and coordination of quality improvement initiatives. Candidates will support regulatory and quality-related activities for Fortrea clients while ensuring compliance with procedures and customer requirements.

Job Details

Position

Regulatory Operations Specialist I

The role involves coordinating regulatory operations and quality-related activities, including document review and approval, quality issue management, corrective and preventive actions, change controls, risk assessments, and continuous quality improvement.

Responsibilities

Key responsibilities include:

• Review and approve documents related to method qualification, method validation, method transfer, investigations, and non-conformances.
• Handle quality issues, Corrective and Preventive Actions (CAPA), and change controls involving clients and their contract laboratories.
• Support departments in maintaining and improving quality culture and Quality Key Performance Indicators (KPIs).
• Participate in Quality Assurance (QA) CSQ meetings, CAPA board meetings, quality improvement programs, and business connect meetings, as appropriate.
• Collaborate with stakeholders and business partners to identify improvement opportunities and achieve objectives.
• Participate in data-driven risk assessments, including risk identification, analysis, and evaluation.
• Develop risk mitigation plans and support CAPA initiatives.
• Ensure quality and compliance with established procedures and customer requirements.
• Identify potential issues, troubleshoot problems, resolve conflicts, and provide appropriate solutions.
• Support regulatory operations involving the creation, revision, compilation, and approval of specifications, regulatory documents, and labeling documents across the product lifecycle.

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.

Required Skills and Competencies

The responsibilities described in the job posting require the ability to:

• Review and approve quality and regulatory documentation.
• Manage quality issues, CAPA, and change controls.
• Conduct risk assessments and support risk mitigation planning.
• Maintain compliance with procedures and customer requirements.
• Collaborate effectively with stakeholders and business partners.
• Troubleshoot problems and resolve conflicts.
• Contribute to continuous quality improvement initiatives.

Application Link