Regulatory and Start Up Specialist
1 day ago
Job Overview
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.Fluent in Arabic and Englis.
Essential Functions
Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
Prepare site regulatory documents, reviewing for completeness and accuracy.
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
Review and provide feedback to management on site performance metrics.
Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
Inform team members of completion of regulatory and contractual documents for individual sites.
Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
Perform quality control of documents provided by sites.
May have direct contact with sponsors on specific initiatives.
**Qualifications**:
Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience.
In-depth knowledge of clinical systems, procedures, and corporate standards.
Good negotiating and communication skills with ability to challenge, if applicable.
Knowledge of applicable regulatory requirements, including local regulations,, SOPs and company’s Corporate Standards.
Understanding of regulated clinical trial environment and knowledge of drug development process.
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
-
Regulatory Affairs Specialist
3 days ago
مصر, Egypt Alcon Full timeThe Regulatory Affairs Specialist is responsible for coordinating various regulatory affairs activities including but not limited to; products submissions, renewals and updates by coordinating between plants and agents and continuously communicating with all parties involved (including governmental and official authorities) to ensure timely submission and...
-
Senior Regulatory Affairs Specialist
2 weeks ago
مصر, Egypt Johnson & Johnson Full timeJohnson & Johnson Medtech is recruiting for a** Senior Regulatory Affairs Specialist** to** **be located in Cairo, Egypt. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and...
-
Regulatory Affairs Specialist
1 week ago
مصر, Egypt Alcon Full timeRegulatory Affairs Specialist - French West African Countries At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we...
-
Regulatory Affairs Specialist
7 days ago
مصر, Egypt Medtronic Full time**Careers that Change Lives** We are a company who inspiring the extraordinary, for more than 70 years, we have led the way with purpose-driven healthcare technology. That history compels us to relentlessly pursue therapies that change lives. The role is opened to continue our daily milestone in serving our patients & partners and give them the highest...
-
Mea Large Project Start-up Lead
3 days ago
مصر, Egypt NOKIA Full time**Come create the technology that helps the world act together** Nokia is committed to innovation and technology leadership across mobile, fixed and cloud networks. Your career here will have a positive impact on people’s lives and will help us build the capabilities needed for a more productive, sustainable, and inclusive world. We challenge ourselves...
-
Fintech & Start-ups Assistant Sales Mana
1 week ago
مصر, Egypt Vodafone Full time**Role Purpose**: This role is a critical contributor for positioning Vodafone as the leading Global digital partner of fintech’s and start-up companies based in Egypt **Job Responsibility**: 1. Lead the account managers to develop and implement business plans and sales strategy for our Accounts that ensure attainment of sales goals, profitability &...
-
Develop Within Regulatory Affairs, Ra Specialist
2 weeks ago
مصر, Egypt NonStop Consulting Full timeThis role would be a great chance to start your career within Regulatory Affairs department or continue your development and improve your experience and skills to become a successful Regulatory Affairs professional working for a world leader in Medical Devices field. Regulatory Affairs is a very sought after field and you will be able to learn lots and use...
-
Regulatory Affairs Specialist
1 day ago
مصر, Egypt Target Recruitment & HR Solutions Full time**Job Requirements**: - Pharmaceutical/Science Bachelor’s Degree or any related field. - 1-2 years experience in Regulatory Affairs, preferably with an FMCG/ pharmaceutical company - cosmetics an asset. - Local knowledge of some MENA regulations for cosmetics, medical devices, or pharmaceutical products. - Fluent in French. - Strong verbal and written...
-
Senior Regulatory Affairs Associate
1 day ago
مصر, Egypt Johnson & Johnson Full timeA global leader in health and personal care, with over 125,000 employees in over 275 companies in 60 countries. We work with healthcare partners to touch the lives of more than a billion people every day worldwide. “By caring, one person at a time, we aspire to help billions of people live longer, healthier, happier lives.” Johnson & Johnson Innovative...
-
Partnerships Sr. Specialist
1 day ago
مصر, Egypt Vodafone Full time**Role Purpose**: As a Partnerships Sr. Specialist you will be handling the content department’s day to day operations, starting with contractual agreements, alignment with legal and regulatory departments and managing partner and vendor payment across all verticals, in addition to Leading on Partnerships Integration pipeline and Partnership Dashboard...