Fortrea Hiring For Regulatory Operations Expert

Responsibilities

• Act as a scientific owner for the development of high‑quality CMC documentation related to pharmaceutical raw materials and excipients
• Translate complex analytical, chemical, and manufacturing data into scientifically rigorous justifications
• Ensure scientific content is aligned with Quality‑by‑Design principles and clearly supports control strategies
• Integrate and critically interpret analytical chemistry data, including physicochemical characterization
• Apply organic and inorganic chemistry principles to assess material composition, chemical reactivity, and degradation pathways
• Support scientifically sound impurity and risk justifications
• Identify analytical data gaps and define scientifically appropriate strategies to close them
• Provide scientific assessments on the impact of material attributes on pharmaceutical manufacturing processes and unit operations
• Support technology transfer, PPQ, and commercial manufacturing by documenting material‑process interactions
• Ensure scientific conclusions reflect manufacturing reality, robustness, and process capability
• Ensure documentation is fully aligned with global regulatory and compliance expectations
• Support regulatory submissions, variations, and health authority interactions by providing clear, defensible scientific rationales
• Maintain strong traceability between experimental data, conclusions, and regulatory positions throughout the product lifecycle
• Act as a scientific interface between MSAT, Analytical Development, Formulation, Manufacturing, Quality, and Regulatory Affairs
• Engage with external suppliers, contract laboratories, and technical experts to clarify chemistry‑ and material‑related questions
• Contribute actively to knowledge management within MSAT by ensuring scientific learnings are captured in a reusable, lifecycle‑oriented manner
• Develop and maintain a deep understanding of pharmaceutical product lifecycle and regulatory requirements
• Collaborate with cross-functional teams to ensure alignment and effective communication
• Develop and implement process improvements to increase efficiency and effectiveness
• Provide training and guidance to junior staff members
• Participate in audits and inspections to ensure compliance with regulatory requirements
• Develop and maintain relationships with external partners and stakeholders
• Stay up-to-date with industry trends and developments
• Participate in continuous improvement initiatives
• Develop and implement strategies to mitigate risks and ensure compliance
• Collaborate with quality assurance teams to ensure compliance with regulatory requirements
• Develop and maintain a thorough understanding of GxP and ICH-GCP guidelines
• Participate in the development and review of standard operating procedures
• Collaborate with regulatory affairs teams to ensure compliance with regulatory requirements

Skills

• Strong understanding of pharmaceutical product lifecycle and regulatory requirements
• GxP and ICH-GCP guidelines
• Analytical chemistry and material characterization
• Organic and inorganic chemistry relevant to pharmaceutical materials
• Pharmaceutical manufacturing processes and unit operations
• CMC relevant scientific documentation
• Material qualification and risk assessments
• Comparability and lifecycle justifications
• Regulatory facing scientific narratives
• Ability to independently analyze complex datasets
• Draw defensible conclusions and clearly articulate scientific rationale
• Familiarity with pharmaceutical compliance, including GMP expectations for materials, suppliers, and lifecycle change control
• 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
• Good organizational and time management ability
• Good analytical capabilities and Customer focus
• Good review skills and concern for quality
• Scientist mindset with a strong sense of ownership and accountability for scientific quality
• Analytical, structured, and rigorous in data interpretation and verification
• Proactive and confident in engaging senior scientific, manufacturing, and regulatory stakeholders
• Strong communicator who can convert complex science into globally aligned, regulator ready CMC knowledge

Company Overview

Fortrea is a leading pharmaceutical company dedicated to developing and manufacturing high-quality products . With a strong focus on innovation and customer satisfaction, we strive to make a positive impact on the lives of patients around the world . Our company culture values proactive ownership, precision, and goal-oriented individuals who are passionate about making a difference . We offer a dynamic and supportive work environment that encourages collaboration, creativity, and growth . As a Regulatory Operations Expert, you will play a critical role in ensuring the quality and compliance of our products, working closely with cross-functional teams to drive success .

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