Director, Regulatory Affairs Operations

Fortrea

15+ years

Not Disclosed

Pune

10 Feb. 4, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Director, Regulatory Affairs Operations

Location: Pune
Category: Clinical
Job ID: 257

About Fortrea:

Fortrea is a leading global contract research organization (CRO) with decades of clinical development experience, offering pharmaceutical, biotechnology, and medical device customers innovative clinical development, patient access, and technology solutions across over 20 therapeutic areas. Operating in around 100 countries, Fortrea is transforming drug and device development worldwide.

Role Overview:

As the Director of Regulatory Affairs Operations, you will be responsible for leading the regulatory affairs functions for global clients, overseeing the regulatory project management lifecycle, and ensuring exceptional service delivery through a team of managers and specialists. You will be key in driving the development of regulatory strategies, managing post-approval lifecycle maintenance, and fostering client satisfaction.

Key Responsibilities:

Lead and manage a cross-functional team of regulatory affairs professionals to support various regulatory activities such as global specification management, toxicology, and packaging material qualification for a diverse product portfolio (cosmetics, pharmaceuticals, medical devices, biologics).
Manage regulatory affairs projects across all geographies (US, EU, APAC, MENA, LATAM, CIS).
Set up and guide a matrix team of regulatory specialists to manage the post-approval lifecycle maintenance.
Lead business development efforts, including RFI/RFP responses and bid defense activities for new regulatory affairs opportunities.
Provide direction for the development and training needs of regulatory affairs staff.
Define, implement, and continuously assess RA strategies for timely submissions in post-approval lifecycle maintenance.
Interface with project management and compliance teams to assess metrics, manage quality issues, and ensure customer satisfaction targets are exceeded.

Qualifications:

Experience: Minimum of 15 years in the pharmaceutical industry within Regulatory Affairs or Operations, with at least 10 years in international regulatory affairs/operations.
Skills: Expertise in project governance, escalation, issue resolution, P&L management, budgeting, and forecasting.
Strong negotiation, written and verbal communication skills, with the ability to manage relationships across diverse stakeholders.
Experience in transitioning business processes to offshore locations.

Why Join Fortrea?

Fortrea is seeking motivated problem-solvers who are passionate about overcoming barriers in clinical trials. By joining our team, you’ll be part of a collaborative environment where personal growth is encouraged, and global impact is a priority.

For more information, visit www.fortrea.com.

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Director, Regulatory Affairs Operations

Job Description

Director, Regulatory Affairs Operations

About Fortrea:

Role Overview:

Key Responsibilities:

Qualifications:

Why Join Fortrea?

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