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Senior Specialist Regulatory Affairs/ Regulatory Quality – French Speaker

Job Description

We are hiring a regulatory /quality role and looking for individual contributor who are fully proficient in applying regulatory /Quality knowledge and can work with high sense of ownership under limited supervision.

This role is reporting to Associate Director Regulatory affairs Near east, middle east and Africa and based in Egypt

Essential Functions Regulatory Role

  • Act as a Regional Regulatory affairs lead and strategist on complex regulatory projects, who is able to create and follow through project strategy on country level in north/west Africa region

Act as client’ representative in front of health authorities and with different client partners (Agents/distributes) in several countries.

  • Prepare, review and submit regulatory documentation (for example : CTD submissions), as appropriate; follow through post approval commitments.
  • Establish strong relationships with stakeholders; present regulatory projects and progress, discuss issues and customer comments;
  • Act as an Subject matter expert implementing Regulatory knowledge in, Quality/Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing/ Change assessments; or as applicable.

Up to date with regulatory intelligence information in different health authorities, communicating to clients and working groups to define best strategy and anticipate future trends.

  • Understands the Scope of Work, deliverables and management of budget for several given projects and manages workload as appropriate;
  • May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training/ development/on-boarding and internships;
  • Present to clients on complex regulatory processes at large full service bid defense meetings;
  • May act as reviewer for regulatory standard operating procedures, as assigned and appropriate;
  • Performs other tasks or assignments, as delegated by Regulatory management;

Essential Functions Quality Role

Adopt and implement the global Quality Management Plan within the scope of the assignment with the support of a mentoring Quality Manager/Senior Quality Specialist, this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness.

May provide assistance during audits and regulatory inspections to the operational teams to the extent agreed with Quality Management and as required by the applicable SOPs.

  • Prepare periodic reports to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives.
  • Upon agreement with the Line Manager: Perform any other reasonable tasks as required by the role. ;

Qualifications

  • Degree in Life science or related discipline is a must. Professional post graduate degree is a plus

High English proficiency, French proficiency is a must.

  • At least 3-5 years relevant experience in regulatory national and/or regional scope of work in north/west Africa

At least 3-5 years relevant experience in regulatory quality role

  • Good understanding of the regulations and related guidelines in gulf and north /west Africa region

Good understanding of Regulations (Pharmaceutical and Biological is a must).

Good knowledge of different regulatory dossiers : CTD, e-CTD, NeeS, ..is a must.

Capacity to read and understand high level SOPs, e-trainings, work easily on veeva and collaborate according to ways of work

  • Possesses a specific regulatory and technical expertise;
Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes. Knowledge of National and International Regulations and Drug Development processes.

  • Knowledge of Pharmaceutical industry operations.
  • Good, solid interpersonal communication and organization skills;
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients;
  • Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable;
  • Demonstrates self-motivation and enthusiasm; high sense of ownership

If you think you are able to bring to the role ability to adapt rapidly changing environment, problem solving attitude and constant readiness to upgrade, please apply.

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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

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