Regulatory Operations Expert – Mumbai at Fortrea

Are you an experienced regulatory affairs professional seeking a senior leadership role in Mumbai? Fortrea invites applications for a Regulatory Operations Expert to manage global regulatory operations, project delivery and team performance. This full-time role offers you the chance to spearhead regulatory lifecycle activities—from specifications, labeling and CMC documentation to global submissions (US, EU, Japan & ROW)—while building, mentoring and leading a high-performing team. Join a global CRO with a rich legacy of innovation and execution.

Responsibilities

• Manage day-to-day operations and delivery for regulatory operations engagements, including overseeing assigned projects for lifecycle maintenance.
• Facilitate coordination, support preparation, compilation and review of regulatory documents (CMC, product quality, labeling) for submissions to US, EU, Japan and other regions.
• Oversee, mentor and develop team members: set direction, perform performance reviews, address HR issues, assign resources to projects.
• Work closely with clients to ensure satisfaction, transition, delivery and that services meet or exceed Service Level Agreements.
• Analyse project status; when needed revise scope, schedule or budget to meet project requirements.
• Report project outcomes and risks to senior management; escalate issues according to work plan.
• Support development of tools and processes; drive cost-effective measures and continuous improvement in process and operational efficiency.
• Work with QA department to develop SOPs, training material and provide training to team members.
• Monitor domestic & international regulatory developments; participate in audits (client or agency).
• Take part in cross-functional meetings, collaborate with HR to identify training needs and conduct workshops.
• Consistently contribute innovative solutions to technical/operational problems and cascade information from internal/external meetings to stakeholders.
• Assist with generation and review of SOPs/Work Instructions and their implementation, and demonstrate company values consistently.

Qualifications

Minimum Required:

• Bachelor’s degree in Pharmacy or related science (or equivalent); OR Bachelor’s degree in Engineering/B.Tech/Packaging/Polymer/Printing stream with at least 10–13 years of relevant experience (Packaging Postgrad/Diploma preferred).
• At least 5+ years of project management and people management experience is desirable.
• Industry experience of 10–13 years relevant to Regulatory Affairs/Quality Assurance or other applicable departments (analytical science, packaging, formulation science, material management, drug development/manufacturing).
• Excellent verbal, written and presentation skills.
• Strong leadership capabilities, attention to detail, multi-tasking ability and ability to influence line/middle management.
• Experience coaching project team members to strengthen their skills.
• Ability to anticipate problems and take corrective action.
• Experience facing internal or external audits.
• Knowledge of medical/drug terminologies, medical device reporting, GxP requirements, worldwide regulatory requirements and adverse event reporting is desirable.
• Knowledge of ICH guidelines is expected.

Preferred Qualifications:

• Master’s or PhD in Pharmacy/related science; or Engineering/B.Tech packaging stream with 10–13 years of experience.
• Certification/diploma in Regulatory Affairs.
• Knowledge of data management systems, pharmaceutical product life-cycle, Management Information Systems (MIS).
• Minimum 5+ years of people/project management.

Benefits & Why You Should Apply

• Opportunity to lead global regulatory operations for a top global CRO with established presence across ~100 countries.
• Strategic role in Mumbai with full-time employment, enabling you to drive both operations and people leaders.
• Work across major regulatory jurisdictions (US, EU, Japan, ROW) for product lifecycle and submissions giving you strong global exposure.
• Build and develop talent, influence process improvements, and shape SOPs, training and operational excellence.
• Join a company that values innovation, quality and collaboration — Fortrea emphasises “agility at scale”, “insight and experience”.
• Travel opportunity (5-10 %) to support business/project needs.

Application Instructions

Application Link