Assoc. II, Administrative Services

4 weeks ago


Riyadh, Ar Riyāḑ, Saudi Arabia Organon Full time

The Position

The RA associate will work on preparing different types of submissions for various products. This role will report to the PV/RA Country Lead.

Responsibilities

  • Prepare regulatory submissions and liaise with SFDA, serving as the primary contact with Health Authority.
  • Ensure product activities comply with SFDA, Regulations, guidelines, and company policies.
  • Provide guidance on regulatory requirements to scientists and manufacturers.
  • Review data accurately and provide technical assessments.
  • Interpret and apply relevant regulatory guidelines.
  • Coordinate efforts for preparing regulatory documents.
  • Maintain communication with regulatory agencies.

Required Education, Experience and Skills

  • Understand Saudi Food and Drug Act, Regulations, and regulatory affairs concepts.
  • Familiarity with global regulatory affairs processes.
  • Knowledge of Health Authority requirements for Clinical and CMC submissions.
  • Fluent in Arabic-English (written and oral).
  • Effective verbal and written communication skills.
  • Proficient in document practices and office applications.
  • Experience with compliance databases and computer systems.
  • Strong time management and organizational skills.
  • Focus on accuracy and quality.
  • Good at collaborating and maintaining compliance mindset.
  • Courageous and candid.
  • Minimum 6 months experience in a Registration Department.
  • Minimum B.Sc. in pharmacy or life science.

Secondary Job Description

Who We Are:

Organon is dedicated to providing innovative health solutions for women and their families, aiming to enhance their quality of life. With a strong focus on Women's Health, biosimilars, and diverse health solutions, we strive for a better tomorrow for every woman.

We encourage applications from candidates with diverse backgrounds and are committed to fostering an inclusive environment for all.

Annualized Salary Range

Employee Status:

Temporary (Fixed Term)

Number of Openings:

1

Requisition ID:R526002



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