Global Regulatory Affairs Manager (homebased) job opportunity at IQVIA Holdings, Inc..

Home Jobs In United Arab Emirates Tag: Job Global Regulatory Affairs Manager (homebased) position at IQVIA Holdings, Inc.


bot
IQVIA Holdings, Inc. Global Regulatory Affairs Manager (homebased)
Experience: 10-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeOND
loacation Dubai, United Arab Emirates, United Arab Emirates
loacation Dubai, United ..........United Arab Emirates

No visa or accommodation sponsorship You will be responsible for regulatory activities required at a country level for pharmaceutical products, including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval etc. ensuring regulatory compliance in the applicable market(s) As part of the IQVIA Global Regulatory Affairs department, you will be working with our clients – global pharmaceutical companies. JOB OVERVIEW Essential Functions •Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries •Submit submissions such as renewals/ variations/ new applications filings/ MAH transfers to the local Health Authority and EMA and follow up on the local regulatory approval process for designated countries •Preparation of local Product Labelling (e.g. SmPC, PIL), in local language for designated countries •Artwork review and approval in client systems •Manage multiple pharmaceutical products •Act as subject matter expert in regulatory processes • Acts as a Regulatory Team Leader on more complex projects, which may include authoring of regulatory documentation, filling application forms.   • Establishes relationships with customers; may meet face to face to discuss regulatory issues, present lessons learned and discuss customer comments • Acts as a Subject matter expert in Regulatory knowledge in Chemistry, Manufacturing and Controls or Lifecycle Maintenance / Marketing Authorization Transfers / Labeling/ Publishing. • Project budget management • Give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development • possible exposure to present to clients on complex regulatory processes bid defense meetings • Act as reviewer for regulatory standard operating procedures • Prepare and deliver internal regulatory training if required MINIMUM REQUIRED EDUCATION AND EXPERIENCE Experience Typically requires 8-10+ years of prior relevant experience. Education Master's Degree in Life science or related discipline Skills and Abilities Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls) relevant regulatory guideline related guidelines Possesses a specific regulatory or technical expertise Interpersonal communication (oral and written) and organization skills Ability to establish and maintain effective working relationships with coworkers, managers and clients Demonstrates self-motivation and enthusiasm Ability to adapt quickly to a rapidly changing environment Knowledge of Maintenance of marking Authorization Experience of preparing variation, renewal packages and artwork approvals. Fluent in English language and able to effectively communicate complex business language to those who speak English as a second language. Must be fluent in Arabic #LI-Remote IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

Other Ai Matches

Local Contact for Pharmacovigilance with Estonian and English language Applicants are expected to have a solid experience in handling Job related tasks
Sr. Consultant Applicants are expected to have a solid experience in handling Job related tasks
Informatore Medico Scientifico (Bergamo) Applicants are expected to have a solid experience in handling Job related tasks
Pharmaberater m/w/d Orphan Drugs, HKL/Kardiologie Applicants are expected to have a solid experience in handling HKL/Kardiologie related tasks
IQVIA - Per Diem - MedTech Travel Clinical Educator - New Orleans, LA Applicants are expected to have a solid experience in handling LA related tasks
National Account Manager Applicants are expected to have a solid experience in handling Job related tasks
Freelance- Translators/Linguists, English into Rangi Applicants are expected to have a solid experience in handling English into Rangi related tasks
Coordinator CS&MS Chile Applicants are expected to have a solid experience in handling Job related tasks
Software Development Engineer 2 Applicants are expected to have a solid experience in handling Job related tasks
Evening Licensed Vocational Nurse (LVN) Applicants are expected to have a solid experience in handling Job related tasks
Senior Manager Security Architect Applicants are expected to have a solid experience in handling Job related tasks
IT-Systemadministrator – Microsoft Infrastruktur (m/w/d) - full remote Applicants are expected to have a solid experience in handling Job related tasks
E-commerce Manager Applicants are expected to have a solid experience in handling Job related tasks
Account Manager Applicants are expected to have a solid experience in handling Job related tasks
Freelance- Translators/Linguists, Indonesian into English Applicants are expected to have a solid experience in handling Indonesian into English related tasks
Clinical Business Development Director (New England Biotech) Applicants are expected to have a solid experience in handling Job related tasks
Clinical Trial Psych Rater - Thai Speaking Applicants are expected to have a solid experience in handling Job related tasks
Principal, Emerging Biopharma Analytics Applicants are expected to have a solid experience in handling Emerging Biopharma Analytics related tasks
Director, Laboratory Operations Applicants are expected to have a solid experience in handling Laboratory Operations related tasks
Vaccines Key Account Manager Applicants are expected to have a solid experience in handling Job related tasks
咨询顾问 Consultant, MC, China Applicants are expected to have a solid experience in handling MC, China related tasks
Freelance- Translators/Linguists, English into Italian Applicants are expected to have a solid experience in handling English into Italian related tasks
Delegad@ AP-Alicante N1 Applicants are expected to have a solid experience in handling Job related tasks