- 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.
- 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.
- Excellent word processing, presentation & spreadsheet application skills.
- 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.
- Minimum of 6 months experience in a Registration Department, dealing with most aspects of registration, with sufficient working knowledge of the subject area to require minimal supervision from the Manager.
- 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.
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Assoc. II, Administrative Services - Canada - Organon LLC
Description
Assoc. II, Administrative Services page is loaded
Assoc. II, Administrative Services
Apply locations SAU - Riyadh - Riyadh time type Full time posted on Posted Yesterday job requisition id R526002Job Description
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
Required Education, Experience and Skills
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.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at .
Search Firm Representatives Please Read Carefully
Organon LLC , does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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:
1About Us
At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women's health and other important therapeutic areas. We are committed to becoming the world's leading women's health company investing in innovations that support women's wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.
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