Job Title: Director, Regulatory Affairs Operations
Location: Pune
Category: Clinical
Job ID: 257
Company Overview:
Fortrea is a leading global contract research organization (CRO) with a focus on scientific rigor and clinical development. We provide comprehensive clinical development, patient access, and technology solutions across 20+ therapeutic areas, supporting pharmaceutical, biotechnology, and medical device customers globally. With operations in approximately 100 countries, we are transforming drug and device development to benefit partners and patients.
For more information about Fortrea, visit: www.fortrea.com
Job Overview:
The Director of Regulatory Affairs Operations will lead and manage regulatory projects, ensuring excellence in service delivery. This role involves managing a team of delivery managers and project managers to handle global regulatory projects across various industries, including pharmaceuticals, medical devices, cosmetics, and biologics.
Summary of Responsibilities:
Regulatory Project Management: Own and manage regulatory projects, exceeding service level agreements (SLAs) and ensuring successful service delivery.
Team Leadership: Lead a cross-functional team of regulatory affairs specialists to support global specification management, raw material qualifications, change control, toxicology, and other regulatory activities.
Lifecycle Management: Manage the post-approval lifecycle for global product portfolios, including cosmetics, pharmaceuticals, medical devices, and biologics.
Business Development: Participate in business development activities, including RFI and RFP responses, and lead bid defense efforts for potential new regulatory projects.
Staff Guidance: Provide direction and guidance for regulatory affairs staff, ensuring the necessary development and training needs are met.
Regulatory Strategy: Define regulatory affairs strategies to meet submission timelines and continuously assess and adjust strategies as necessary.
Collaboration with Other Teams: Work with project management and audit teams to generate metrics, resolve escalations, and ensure quality and compliance.
Customer Satisfaction: Ensure customer satisfaction targets are met and exceeded.
Qualifications:
Minimum Required:
Experience:
Minimum of 15 years of experience in regulatory affairs or operations within the pharmaceutical industry.
At least 10 years of international regulatory affairs/operations experience, focusing on approvals and post-approval product lifecycle management.
Skills:
Expertise in project governance, escalation, and issue resolution.
Strong P&L management and budgeting experience.
Experience in transitioning business processes to offshore locations.
Excellent written and verbal communication skills.
Ability to manage stakeholder relationships and produce quality materials within tight timeframes.
Strong negotiation skills.
Willingness to work flexible hours.
Preferred Qualifications:
Experience in managing and leading regulatory affairs teams for global customers.
Experience in managing the lifecycle maintenance of a wide range of products, including pharmaceuticals, medical devices, and biologics.
Physical Demands/Work Environment:
Location: Office-based in Pune or as determined by the line manager.
Fortrea’s Culture & Values:
Fortrea is committed to overcoming barriers in clinical trials through innovation and collaboration. We believe in a supportive and growth-oriented environment that enables team members to make a meaningful global impact. The Fortrea FOUR culture emphasizes:
Forward Together
Own It
Uphold Integrity
Respect People
Equal Opportunity Employer:
Fortrea is an Equal Opportunity Employer (EOE/AA) and is committed to fostering diversity and inclusion in the workforce. We do not tolerate discrimination or harassment and base employment decisions on business needs and individual qualifications.
Accommodation Requests:
If you require accommodations for your job application, interview, or other aspects of the hiring process, please contact us at:
Email: taaccommodationsrequest@fortrea.com
(Note: This email address is for accommodation requests only. Please do not use it for checking application status.)
For more detailed information on our recruitment policies, visit Fortrea’s Privacy Statement.
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