Sr. Specialist - Regulatory Affairs

Overview

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism. Our core values : Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees. Designation :

Regulatory Affair Senior Officer Department :

Scientific Office / Riyadh K.S.A

Summary of Responsibilities :

To facilitate all regulatory activities between Julphar headquarter and the local authority.

To review and coordinate a database for regulatory activities and documentation.

Provide input to strategic decisions affecting the functional areas of responsibility.

Detailed Job Responsibilities :

Liaise with RA-HQ for annual regulatory activity plans (new registrations, renewals, post-approval activities).

Acknowledge receipt of regulatory files from RA-HQ and provide expected submission dates to Health Authority (HA).

Review regulatory files before HA submission to ensure compliance with guidelines, scientific accuracy, clarity, and to expedite submission.

Maintain effective relationships with health authorities, liaise, and negotiate when necessary.

Provide acknowledgment receipt to RA-HQ upon submission of each application.

Follow up regularly with regulatory authorities on submitted applications.

Receive authority queries, filter fulfilled requirements, and forward to RA-HQ within 2 working days.

Collaborate with RA-HQ to ensure timely compliance with authority timelines and coordinate with HA for timeline extensions if needed.

Review and confirm HA registration certificates / decisions for discrepancies and share approval decisions with RA-HQ within 3 working days.

Review the master regulatory tracker regularly and communicate updates to RA-HQ within 2 days.

Interpret authority rules and changes, and update RA-HQ with circulars, new decisions, and guideline updates within 3 working days.

Report any change in product pricing to RA-HQ immediately.

Provide a monthly report for all regulatory transactions, including submissions, approvals, and query handling.

Be proactive in the dynamic regulatory environment of the region / countries, especially regarding guidelines and pricing, and provide necessary feedback.

Technical Qualifications :

Bachelor of Pharmacy.

Requirement (Soft Skills & Attributes) :

Computer skills (Ms Office, Google Drive, spreadsheet, and database).

Planning (Assessment, analysis, problem solving, collaboration and communication skills).

Management skills (prioritization, task separation and multiple task handling).

Good communication and presentation skills.

Maintaining a comprehensive knowledge of local authority regulation and sufficient knowledge of global regulatory legislation and guidelines

We value people from different backgrounds. Could this be your story? Apply today or visit read more about us and the journey of Julphar

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