Global Regulatory Affairs Manager (homebased) at IQVIA

Dubai, Dubai, United Arab Emirates

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

NoVisa

PharmaceuticalIndustries

Requirements

Master's Degree in Life science or related discipline
Typically 8-10+ years of prior relevant experience
Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls) and relevant regulatory guidelines
Specific regulatory or technical expertise
Strong interpersonal communication (oral and written) and organization skills
Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Self-motivation and enthusiasm
Ability to adapt quickly to a rapidly changing environment
Knowledge of Maintenance of Marketing Authorization
Experience preparing variation, renewal packages, and artwork approvals
Fluent in English and able to communicate complex business language to non-native speakers
Fluent in Arabic

Responsibilities

Manage local regulatory submission preparation in collaboration with internal and external stakeholders based on agreed strategy for designated countries
Submit renewals, variations, new applications, and MAH transfers to local Health Authorities and EMA, and follow up on approval processes
Prepare local Product Labelling (e.g., SmPC, PIL) in local language for designated countries
Review and approve artwork in client systems
Manage multiple pharmaceutical products
Act as subject matter expert in regulatory processes
Act as Regulatory Team Leader on complex projects, including authoring regulatory documentation and filling application forms
Establish relationships with customers, including face-to-face meetings to discuss regulatory issues, lessons learned, and customer comments
Act as subject matter expert in Regulatory knowledge for Chemistry, Manufacturing and Controls, Lifecycle Maintenance, Marketing Authorization Transfers, Labeling, or Publishing
Manage project budgets
Provide guidance to junior colleagues, including feedback on technical documents, and assist in their training and development
Present to clients on complex regulatory processes in bid defense meetings (possible exposure)
Act as reviewer for regulatory standard operating procedures
Prepare and deliver internal regulatory training if required
Handle regulatory activities at country level, including maintenance, approvals, marketing authorization transfers, Health Authority communication, and ensuring regulatory compliance

Skills

Regulatory Submissions

SmPC

PIL

Artwork Approval

CMC

MAH Transfers

EMA

Health Authority Communication

Labeling

Publishing

Project Management

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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