Regulatory and Start Up Specialist
4 months 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 and Start Up Specialist
4 months ago
مصر, Egypt IQVIA Full time**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...
-
Regulatory Affairs Specialist
5 months 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...
-
Export & Regulatory Specialist
7 months ago
مصر, Egypt Skretting Full time**JOB CONTEXT** The Regulatory Specialist reports hierarchically into the Regulatory Manager and may have a regional or global scope. **KEY ACCOUNTABILITIES** **Regulatory and Compliance Management** Investigate all kinds of incidents and reports and provide expert advice to more senior colleagues. Minimize risk exposures and ensure adherence with...
-
Senior Regulatory Affairs Specialist
5 months 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
4 months ago
مصر, Egypt Medtronic Full time**Careers that Change Lives** We are a company 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 level...
-
Regulatory Labeling
4 months ago
مصر, Egypt Johnson & Johnson Full timeJohnson & Johnson is recruiting for a Regulatory Labeling & Compliance Specialist, located in Cairo, Egypt. **Key Responsibilities**: - Perform labeling and artwork activities: create and update labeling documents, annotate artworks, perform proofreading, coordinate labeling submission and implementation, follow up on approvals and implementation...
-
Regulatory Affairs Specialist
5 months 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
5 months ago
مصر, Egypt Medtronic Full time**Careers that Change Lives** We are a company 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 level...
-
Regulatory Affairs Specialist
5 months 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...
-
Drug Regulatory Affairs Specialist
5 months ago
مصر, Egypt Orchidia Pharmaceutical Industries Full time**وصف الوظيفة**: **Purpose of the job**: **Primary Tasks**: - Responsible for Pharmaceutical products, Dietary supplement, Medical Devices and cosmetics products in the following areas. - Oversee the regulation process for products requiring governmental or international approvals. - Update licensing and collects information on registration...
-
Regulatory Affairs Specialist
5 months ago
مصر, Egypt Zoetis Full time**Position Summary** Accountable for the achievement of the local affiliate, Cluster and Corporate objectives, in collaboration with the affiliate RA Manager to support in RA Egypt affiliate and Levant region, and provide Regulatory Affairs support to the local affiliate to help the market(s) achieve their revenue and growth targets: - Obtain new product...
-
Regulatory Accountant
4 months ago
مصر, Egypt Bupa Global Full timeRegulatory Accountant **Job Description**: **Senior Regulatory Accountant** **Cairo, Egypt** **Fixed term contract** **Full time 40 hours per week** Working in our support functions you'll play a key part in helping our customer facing colleagues deliver exceptional standards of customer service and patient care. No matter your role, you'll have an...
-
Regulatory Affairs Specialist
5 months ago
مصر, Egypt Takeda Pharmaceutical Full time**_ OBJECTIVES:_** - Responsible for directing all day to day regulatory affairs activities in the assigned countries within Oman, Bahrain & Qatar countries to ensure compliance with all regulations. - Implements regulatory strategies for the earliest possible product approvals and ensures the timely creation, preparation, and achievement of organized valid...
-
Officer, Regulatory Affairs
5 months ago
مصر, Egypt Hikma Pharmaceuticals PLC Full time**Description**: Regulatory Affairs Officer is responsible for performing Regulatory activities to maintain product registrations, product licenses and relevant life cycle management activities within the defined timelines and in full compliance with the legislations and regulations. **Duties & Responsibilities**: - Obtain marketing authorizations and...
-
Senior Regulatory Affairs Associate
4 months 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...
-
Regulatory Affairs Process
5 months ago
مصر, Egypt Johnson & Johnson Full time**Position Summary**: In this role, you will ensure that J&J's pharma products, processes, and operations comply with all relevant local, national, and international regulations and standards. You will work across the NEMA region which comprises the Near East, Maghreb, and African countries, meaning that your work will span across a whole continent, shaping...
-
Regulatory Affairs Executive
5 months ago
مصر, Egypt Jamjoom Pharma Full timeAs a Regulatory Affairs Executive, you will be responsible for the day-to-day monitoring of the company’s regulatory activities to ensure compliance with all regulations. You will be a key member of our regulatory affairs team, which is responsible for the company’s regulatory processes and reporting of the regulatory activities. **Responsibilities** -...
-
Regulatory Affairs Specialist/manager- Levant- 6
5 months ago
مصر, Egypt Novasyte Full timeJob Overview Essential Functions: - Act as a Regional Regulatory Team Lead and strategist on complex regulatory projects, who is able to create and follow through project strategy on country level in Middle east and north Africa region. - Act as client’ representative in front of health authorities and with different client partners (Agents/distributes)...
-
Director, Regulatory Affairs
5 months ago
مصر, Egypt اورنچ مصر Full timeAbout the job Director, Regulatory Affairs **Purpose of the job** Managing the regulatory affairs, overseeing the industry practices & ensure all government regulations being met to support the current and future strategic plans of Orange. **Duties and responsibilities** - Ensure coordination and enrichment of the company's strategic plan. - Provide...
-
Regulatory Affairs Associate, Gem
5 months ago
مصر, Egypt Acino Full timeAcino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region and Latin America, and operate in some of the most dynamic countries of the world. We value courage, commitment, trust and empathy and provide an environment that supports...