Administrative Services

6 days ago


Canada Organon LLC Full time
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 R526002 Job Description
Preparation of regulatory submissions and follow up with SFDA.

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.
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.
minimum of 1 year experience in the pharmaceutical Industry is preferable, in a regulatory, medical or laboratory position.
Organon delivers ingenious health solutions that enable people to live their best lives.

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.

A better and healthier every day for every woman.
Please, no phone calls or emails.

Please Note:
Pay ranges are specific to local market and therefore vary from country to country.
Temporary (Fixed Term)

Relocation:

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

Flexible Work Arrangements:

Shift:

Valid Driving License:

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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