Regulatory Affairs Specialist

Job Overview

Kinetic Business Solutions is collaborating with a renowned pharmaceutical company to recruit a Regulatory Affairs Specialist based in Riyadh, Saudi Arabia. The role demands a dedicated professional to manage and oversee regulatory submissions integral to product lifecycle management.

Primary Responsibilities

• Compile, prepare, review, and submit regulatory dossiers related to new product registrations, renewals, modifications, and post-approval changes.
• Collaborate effectively with cross-departmental teams to support product registrations and ongoing lifecycle activities to ensure timely approvals.
• Maintain compliance with relevant regulatory standards, guidelines, and internal company policies in all submissions.
• Monitor submission deadlines and ensure all regulatory obligations are fulfilled promptly.

Candidate Requirements

• Possess a minimum of three years' professional experience in regulatory affairs within the pharmaceutical sector.
• Hold a Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a closely related discipline.
• Demonstrated proficiency in preparing CTD/eCTD regulatory submissions.
• In-depth understanding of pharmaceutical regulatory frameworks and guidelines.
• Experience liaising with the Saudi Food and Drug Authority (SFDA).

Additional Information

Applicants must thoroughly review the criteria as only those fulfilling all the requirements will be considered. All submitted applications are screened, and qualified candidates will receive feedback within five business days. If no contact is made within this period, candidates should consider their application unsuccessful for this cycle.