Director, Regulatory Affairs Operations
Location: Pune
Category: Clinical
Company: Fortrea
Company Overview
Fortrea is a global contract research organization (CRO) with expertise in clinical development, regulatory affairs, patient access, and technology solutions. Operating in nearly 100 countries, Fortrea serves pharmaceutical, biotechnology, and medical device companies across 20+ therapeutic areas.
Role Overview
The Director of Regulatory Affairs Operations will be responsible for managing regulatory projects, ensuring service excellence, and leading a cross-functional team to support regulatory processes across global markets. This role requires extensive experience in regulatory affairs, project governance, and business development.
Key Responsibilities
Regulatory Affairs and Project Management
Own and manage regulatory project accounts, ensuring excellence in service delivery and adherence to Service Level Agreements (SLAs).
Lead a cross-functional team of regulatory affairs specialists supporting:
Global specification management
Raw material qualifications
Change control
Toxicology
Analytical methods and stability reports
Packaging material and labeling for pharmaceuticals, medical devices, biologics, and consumer products
Establish a matrix team for post-approval life cycle maintenance.
Oversee regulatory affairs projects across global markets, including US, EU, APAC, MENA, LATAM, CIS, etc.
Define regulatory strategies to meet submission timelines for post-approval life cycle maintenance.
Continuously assess and adjust regulatory strategies as needed.
Business Development & Stakeholder Management
Lead business development activities, including responding to RFIs and RFPs.
Participate in bid defense efforts for new regulatory affairs project opportunities.
Manage relationships with key stakeholders across different geographies.
Ensure customer satisfaction by exceeding service expectations.
Leadership and Compliance
Guide and develop regulatory affairs staff, ensuring appropriate training and career growth.
Work closely with audit and compliance teams to manage QA-related issues.
Interface with project management office to generate and communicate process and productivity metrics.
Ensure compliance with regulatory standards and internal policies.
Required Experience & Skills
Minimum 15 years of experience in Regulatory Affairs/Regulatory Operations within the pharmaceutical industry.
At least 10 years of international regulatory experience in approvals and post-approval life cycle management.
Strong expertise in project governance, issue resolution, and escalation management.
Proven experience in budgeting, forecasting, and pricing.
Hands-on experience with P&L management.
Experience in transitioning business processes to offshore locations.
Ability to manage relationships with diverse stakeholders.
Excellent written and verbal communication skills.
Strong negotiation and problem-solving abilities.
Capable of producing high-quality materials within tight deadlines.
Willingness to work in a flexible schedule as needed.
About Fortrea
Fortrea is committed to revolutionizing drug and device development by overcoming barriers in clinical trials. The company fosters a collaborative environment, encouraging professional growth and meaningful global impact.
For more information, visit www.fortrea.com.
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