Assoc. Ii, Administrative Services
4 weeks ago
**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
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