Director, Regulatory Affairs Operations

15+ years

Not Disclosed

Pune

10 Feb. 13, 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

Description:
Fortrea, a leading global contract research organization (CRO), specializes in scientific rigor and clinical development. With operations in approximately 100 countries, we provide pharmaceutical, biotechnology, and medical device companies with comprehensive clinical development, patient access, and technology solutions across 20+ therapeutic areas.

Key Responsibilities:

Own and manage regulatory project accounts, ensuring excellence in service delivery and exceeding Service Level Agreements through a team of delivery managers and project managers.
Lead a cross-functional team of regulatory affairs specialists to support global specification management, raw material qualifications, change control, toxicology, analytical methods, stability reports, packaging materials, labeling, and more across a global product portfolio (cosmetics, pharmaceuticals, medical devices, and biologics).
Establish and oversee a matrix team of regulatory affairs professionals to manage post-approval life cycle maintenance.
Lead regulatory affairs functions and oversee project delivery for global customers across geographies including the US, EU, APAC, MENA, LATAM, and CIS.
Participate in and/or lead business development activities, including RFI and RFP responses and bid defense efforts for regulatory project opportunities.
Provide training and development guidance for regulatory affairs staff, ensuring resource availability for projects requiring regulatory submissions.
Define regulatory affairs strategies to meet submission timelines for post-approval life cycle maintenance and continuously assess and adjust strategies as needed.
Interface with the project management office to generate and communicate process and productivity metrics.
Collaborate with the audit and compliance team to address QA-related issues and escalations.
Ensure customer satisfaction targets are met and exceeded.

Experience (Minimum Required):

Minimum 15 years of experience in the pharmaceutical industry within Regulatory Affairs or Regulatory Operations, with at least 10 years of international regulatory experience in approvals and post-approval product life cycle maintenance.
Expertise in project governance, issue resolution, and other project management skills.
Experience in P&L management, business process transitions to offshore locations, budgeting, forecasting, and pricing.
Strong written and verbal communication, interpersonal, and negotiation skills.
Ability to manage relationships across diverse stakeholders and produce quality materials within tight timeframes.
Willingness to work on a flexible schedule.

About Fortrea:
Fortrea is dedicated to revolutionizing clinical trials and accelerating the delivery of life-changing therapies. We provide a collaborative environment that fosters professional growth and global impact. For more information, visit www.fortrea.com.

Equal Opportunity Employer Statement:
Fortrea is an Equal Opportunity Employer committed to diversity and inclusion. We do not tolerate harassment or discrimination of any kind and make employment decisions based solely on business needs and qualifications. We encourage all individuals to apply, regardless of race, religion, gender, age, disability, or any other legally protected status.

For more details on our data collection and privacy practices, please refer to our Privacy Statement. If you require accommodations during the hiring process, contact taaccommodationsrequest@fortrea.com (for accommodation requests only, not application status inquiries).

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Director, Regulatory Affairs Operations

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