Director, Regulatory Affairs Operations

15+ years

Not Disclosed

Pune

10 Jan. 18, 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

Position: Director, Regulatory Affairs Operations
Location: Pune
Category: Clinical
Job ID: 257

Job Overview

Fortrea is seeking a Director, Regulatory Affairs Operations to lead and manage global regulatory projects, ensuring excellence in service delivery, exceeding service level agreements, and effectively overseeing a cross-functional regulatory affairs team. This role involves overseeing post-approval life cycle maintenance, managing regulatory affairs projects, and providing strategic direction for the development and training of regulatory affairs staff.

Key Responsibilities

Project and Team Management:
- Own and manage regulatory project accounts and work with delivery managers and project managers to exceed service delivery expectations.
- Lead a team of regulatory affairs specialists supporting global product portfolios across cosmetics, pharmaceuticals, medical devices, and biologics.
- Set up and manage matrix teams to handle post-approval lifecycle maintenance.
- Lead regulatory affairs functions across US, EU, APAC, MENA, LATAM, and CIS geographies.
Strategy and Development:
- Define and implement regulatory strategies to meet submission timelines for post-approval lifecycle maintenance.
- Continuously assess the appropriateness of regulatory strategies and adjust as needed.
- Provide guidance on development and training needs for the regulatory affairs team.
Business Development:
- Participate in and/or lead business development activities, including RFI and RFP responses, and bid defense efforts for new regulatory affairs project opportunities.
Process and Productivity Management:
- Work with the project management office to generate process and productivity metrics, communicating them in appropriate forums.
Customer Satisfaction and Quality:
- Ensure customer satisfaction targets are met and exceeded.
- Interface with the audit and compliance team to address QA-related issues and escalations within the account.

Experience (Minimum Required)

Minimum of 15 years in the pharmaceutical industry in Regulatory Affairs or Regulatory Operations, with at least 10 years of international regulatory affairs/operations experience.
Expertise in project governance, escalation, issue resolution, and project management.
Experience in P&L management and budgeting, forecasting, and pricing.
Experience transitioning business processes to offshore locations.
Strong written, verbal, and interpersonal communication skills, with the ability to manage diverse stakeholder relationships.
Negotiation skills and the ability to produce quality materials within tight deadlines.
Willingness to work in a flexible schedule.

Company Overview

Fortrea is a global contract research organization (CRO) specializing in clinical development and technology solutions across more than 20 therapeutic areas. With operations in over 90 countries, Fortrea is committed to overcoming barriers in clinical trials and swiftly delivering life-changing therapies to patients.

Equal Opportunity Employer Statement

Fortrea is an Equal Opportunity Employer that values diversity and inclusion in the workforce. We do not tolerate harassment or discrimination and make employment decisions based on qualifications and business needs.

Accommodation

Fortrea provides reasonable accommodations for individuals who require assistance during the hiring process. Contact taaccommodationsrequest@fortrea.com for accommodation requests.

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Director, Regulatory Affairs Operations

Job Description

Job Overview

Key Responsibilities

Experience (Minimum Required)

Company Overview

Equal Opportunity Employer Statement

Accommodation

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