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Director, Regulatory Affairs Operations

10-15 years
Not Disclosed
10 Jan. 28, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Director, Regulatory Affairs Operations

Location: Pune
Category: Clinical
Job ID: 257


About Fortrea

Fortrea is a global contract research organization (CRO) dedicated to scientific rigor and decades of clinical development expertise. Serving pharmaceutical, biotechnology, and medical device clients, Fortrea offers clinical development, patient access, and technology solutions across 20+ therapeutic areas. Operating in ~100 countries, Fortrea aims to transform drug and device development for patients and partners globally.


Key Responsibilities

Regulatory Project Management

  • Own and manage regulatory project accounts, striving to exceed Service Level Agreements (SLAs) through effective leadership of delivery and project managers.
  • Lead cross-functional regulatory teams to support:
    • Global specification management
    • Raw material qualifications
    • Change control
    • Toxicology assessments
    • Analytical methods and stability reporting
    • Packaging materials and labeling for global product portfolios, including cosmetics, pharmaceuticals, medical devices, and biologics.
  • Establish matrix teams to manage post-approval lifecycle maintenance.

Operational Leadership

  • Manage global regulatory affairs functions across multiple geographies (e.g., US, EU, APAC, MENA, LATAM, CIS).
  • Ensure successful delivery of regulatory affairs projects while maintaining compliance and quality.
  • Collaborate with the project management office to generate productivity and process metrics, sharing insights at relevant forums.
  • Interface with the audit and compliance team to address quality assurance (QA) issues and escalations.

Strategic Guidance and Business Development

  • Define regulatory strategies to meet submission timelines for post-approval lifecycle maintenance.
  • Continuously assess and adjust regulatory strategies for ongoing relevance and effectiveness.
  • Lead business development activities, including responding to RFI/RFPs and participating in bid defenses for new regulatory affairs opportunities.
  • Oversee budgeting, forecasting, pricing, and P&L management for regulatory operations.

Team Development

  • Guide and mentor regulatory affairs staff, identifying development and training needs.
  • Ensure adequate staffing for projects requiring regulatory submission services.
  • Foster a culture of excellence and continuous improvement within the team.

Customer Satisfaction

  • Achieve and exceed customer satisfaction targets through quality service delivery.
  • Manage relationships with diverse stakeholders, ensuring clear communication and alignment.

Experience and Skills

Minimum Requirements

  • 15+ years of experience in regulatory affairs or regulatory operations within the pharmaceutical industry.
  • 10+ years of international experience in regulatory approvals and post-approval lifecycle maintenance.
  • Expertise in project governance, issue resolution, escalation, and project management.
  • Proven experience in transitioning business processes to offshore locations.

Technical and Leadership Skills

  • Strong P&L management and budgeting/forecasting skills.
  • Excellent written and verbal communication and interpersonal abilities.
  • Ability to produce high-quality materials within tight deadlines.
  • Strong negotiation and relationship management skills.

Preferred Qualities

  • Willingness to work flexible schedules as needed.
  • Proven ability to manage diverse global teams and foster collaboration.

Why Join Fortrea?

  • Opportunity to lead regulatory operations for innovative clinical trials with global impact.
  • Collaborative and growth-oriented work environment.
  • Commitment to diversity, equity, and inclusion.

Equal Opportunity Employer

Fortrea is an Equal Opportunity Employer (EOE/AA) committed to fostering a diverse and inclusive workforce. Employment decisions are based on qualifications and business needs without discrimination based on legally protected characteristics.

For reasonable accommodation requests, contact taaccommodationsrequest@fortrea.com.

For more information, visit www.fortrea.com.