Assoc. Ii, Administrative Services

7 months ago


Riyadh, Saudi Arabia Merck Full time

**The Position**

The RA associate will be assigned to all submission preparation types and products. The position reports to the PV/RA Country Lead.

**Responsibilities**
- Preparation of regulatory submissions and follow up with SFDA. This includes interacting with Health Authority and being a primary contact with Health Authority with regards to the submissions.
- Ensures that all activities in relation to the products and their maintenance on the Saudi market are in compliance with the SFDA and Regulations, all relevant SFDA guidelines and company policies.
- Advise scientists and manufacturers on regulatory requirements.
- Providing correct and accurate technical review of data or reports
- Examining, identifying, and interpreting relevant regulatory guidelines.
- Advising others on matters that are related to regulatory processes and compliance.
- Coordinating efforts that are related to the preparation of regulatory documents or submissions.
- Developing and maintaining healthy communication with regulatory agencies regarding pre-submission and post submission.

**Required Education, Experience and Skills**
- Awareness of Saudi Food and Drug Act and Regulations and ability to interpret Awareness of regulatory affairs science, concepts, terminology.
- Understanding of company global regulatory affairs organization, processes, compliance expectations.
- Understanding of the Health Authority regulatory requirements for Clinical and CMC submissions.
- Bilingual Arabic-English (written and oral).
- Ability to communicate effectively verbally and in writing.
- Knowledge of Good Documentation Practices.
- Familiar with the use of a large compliance databases.
- Ability to learn new computer interface systems.
- Excellent time management, organizational & planning skills.
- High level of accuracy & quality in work.
- Good collaboration skills.
- Compliance mindset/focused.
- Courage and candor.
- Must be at least B.Sc. in pharmacy or other life science or equivalent. An approx. minimum of 1 year experience in the pharmaceutical Industry is preferable, in a regulatory, medical or laboratory position.

**Secondary Job Description**

**Who We Are**:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

**Search Firm Representatives Please Read Carefully**

**Annualized Salary Range**

**Annualized Salary Range (Global)**

**Annualized Salary Range (Canada)**

**Please Note: Pay ranges are specific to local market and therefore vary from country to country.**

**Employee Status**:
Temporary (Fixed Term)

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites**

**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R526002


  • Technician Ii

    2 weeks ago


    Riyadh, Saudi Arabia Valiant Integrated Services Full time

    The Technician II reports to the Site Manager. - An Electronics Technician II's primary duties include but not limited to: - Applies comprehensive technical knowledge to solve complex problems/tasks by interpreting manufactures manuals, schematics or similar documents. - Performs such tasks as replacing components and wiring circuits, repairing complex...

  • Technician Ii

    7 days ago


    Riyadh, Saudi Arabia Valiant Integrated Services Full time

    The Technician II reports to the Site Manager. A Technician II's primary duties include but not limited to: - Applies comprehensive technical knowledge to solve complex problems/tasks by interpreting manufactures manuals, schematics or similar documents. - Performs such tasks as replacing components and wiring circuits, repairing complex electronic...

  • Accountant Ii

    7 days ago


    Riyadh, Saudi Arabia Security Forces Hospital Program Full time

    **_Job Title:_** Accountant II **_Job Summary: - ** Under the direction of Budget Director and Assistant Budget Director is responsible in monitoring PO Tracking System and assisting in preparing General Ledger, Budgeting and monitoring manpower database. Also, employee is expected to assist the Budget Department Director and other staff members by...

  • HR Specialist Ii

    3 days ago


    Riyadh, Saudi Arabia Security Forces Hospital Program Full time

    **Job Title: HR Specialist II** **Education and Licensure** - Minimum (Bachelor) degree in HR Management, Business Administrative, or any related field from accredited University or College. - Preferred any certifications in human resources such as Human Resource Management (SHRM) and (CIPD). **Professional Experience**: - Minimum of 1 year experience in...

  • HR Specialist Ii

    2 weeks ago


    Riyadh, Saudi Arabia Security Forces Hospital Program Full time

    **Job Title: HR Specialist II** **Education and Licensure** - Minimum (Bachelor) degree in HR Management, Business Administrative, or any related field from accredited University or College. - Preferred any certifications in human resources such as Human Resource Management (SHRM) and (CIPD). **Professional Experience**: - Minimum of 1 year experience in...

  • Field Service Engineer

    7 months ago


    Riyadh, Saudi Arabia OSI Systems, Inc. Full time

    **Overview**: **Position Summary: Saudi National Required** A Field Service Engineer (FSE) II with Raspiscan | AS&E has the primary responsibility of ensuring the users of Rapiscan | AS&E equipment are satisfied with its performance. This is an intermediate level position that will require advanced troubleshooting and diagnostic skills and the ability to...


  • Riyadh, Saudi Arabia King Faisal Specialist Hospital and Research Centre Full time

    Provides administrative and professional support in managing the day-to-day operations of the assigned area. Performs and completes special administrative tasks as assigned. Assists and facilitates the flow of work for the in-line staff of the same area. **Essential Responsibilities and Duties**: 1. Provides full administrative support to the Department...


  • Riyadh, Saudi Arabia King Faisal Specialist Hospital and Research Centre Full time

    Evaluates patient’s skills in the area of speech, language, voice, cognition, swallowing, and case management and establishes a plan of care. Provides independently treatment under periodic supervision as warranted. **Essential Responsibilities and Duties**: 1.Provides quality habilitative/rehabilitative care for patients receiving speech language...


  • Riyadh, Saudi Arabia AS&E Full time

    Overview: **Position Summary**: A Field Service Engineer (FSE) II with Raspiscan | AS&E has the primary responsibility of ensuring the users of Rapiscan | AS&E equipment are satisfied with its performance. This is an intermediate level position that will require advanced troubleshooting and diagnostic skills and the ability to think independently and operate...


  • Riyadh, Saudi Arabia OSI Systems, Inc. Full time

    **Overview**: **Position Summary**: - A Field Service Engineer (FSE) II with Raspiscan | AS&E has the primary responsibility of ensuring the users of Rapiscan | AS&E equipment are satisfied with its performance. This is an intermediate level position that will require advanced troubleshooting and diagnostic skills and the ability to think independently and...


  • Riyadh, Saudi Arabia King Faisal Specialist Hospital and Research Centre Full time

    Provides administrative support and coordination for the assigned supervisor and department. **Essential Responsibilities and Duties**: 1. Provides administrative and coordination support to management department staff by following up on projects relaying information and keeping them informed of pertinent activities. 2. Provides administrative assistance...

  • Associate Ii

    7 months ago


    Riyadh, Saudi Arabia Marsh McLennan Full time

    Associate II - Placement **Company**: Marsh **Description**: Uses significant risk expertise and knowledge of industry and carriers to develop placement solutions that meet client needs. Implements the Placement strategy to achieve growth goals and provide exceptional client service. Develops the go-to-market strategy and articulates the value of...

  • Commi-ii

    7 months ago


    Riyadh, Saudi Arabia Keden International Full time

    Prepare quality bakery items as per outlined recipes, HACCP standards, portion control practices, and items’ presentation guidelines then dispatch prepared orders to different outlets - Take part in the opening and closing duties of the bakery in compliance with the norms and internal procedures and contribute in stocking and receiving goods when needed -...


  • Riyadh, Saudi Arabia Sovereign Group Full time

    Senior Client Services Administrator Guernsey Full Time Senior Client Services Administrator This role involves all aspects of retirement products administration within the office, as well as reporting to the relevant management team. RESPONSIBILITIES Responsibilities will include providing a range of duties to support a growing book of pensions...


  • Riyadh, Saudi Arabia Talent Pal Full time

    We seek a highly organised and detail-oriented Administrative Assistant/Customer Service Representative to join our team. This position is remote, so you can work from anywhere with a stable internet connection. **Responsibilities** - Resolve customer complaints and issues with a positive attitude - Process customer orders and ensure accurate and timely...


  • Riyadh, Saudi Arabia Elite Sports Academy Full time

    **Job Title: Customer Service Administrator** **Location: Riyadh, KSA** **The Company**: An exciting opportunity awaits you at Elite Sports Academy, one of the leading sports services companies in the UAE. We are passionate about delivering top-quality services, including sports coaching and development, complete ECA programs for schools, sports holiday...


  • Riyadh, Saudi Arabia King Faisal Specialist Hospital and Research Centre Full time

    Ensures that Radiology Department patient bookings, orders, and preparations are in line with hospital policies and they are completed in a timely manner through coordination with Radiology Technologists, Radiologists, Physicians, nurses and other health care providers. **Essential Responsibilities and Duties**: 1. Receives and greets patients, employees or...


  • Riyadh, Saudi Arabia BAE Systems Full time

    **WD PCU Operator CAT II** - 00105383 **WD PCU Operator** **CAT** **II** **Location**: **Riyadh. Saudi Arabia** **Grade: 7** **JOB PURPOSE** BAE Systems is the UK Government’s nominated Prime Contractor under the Government-to-Government arrangements that are in place to provide equipment, support and training to Saudi Arabia. We provide maintenance...


  • Riyadh, Saudi Arabia Amentum Full time

    **Arabic-Modern Standard Linguist II**: - R0093735 - Riyadh, Saudi Arabia - Full time - Add to favorites Favorited View favorites Amentum is seeking linguists with excellent English skills to grow our talented and diverse team globally towards our mission’s success. We are looking for dedicated linguist professionals in a variety of languages/dialects to...


  • Riyadh, Saudi Arabia Almarai Full time

    Regional Sales Manager II The Company Almarai is the world’s largest vertically integrated dairy and the region’s largest food and beverage manufacturing and distribution company. Headquartered in the Kingdom of Saudi Arabia, Almarai Company ranked as #1 FMCG Brand in the MENA region and is market leader in all its categories across the GCC. Almarai...