Regulatory Affairs Specialist

With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.

 

This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.

 

About the role

 

Regulatory Affairs Specialist will be responsible to maintain and keep the life cycle of the products of the company valid and accurate at SFDA systems, such as eSDR and GHAD.

 

Key responsibilities

 

Prepare the file as eCTD for new registration submission at eSDR.

Prepare and review the artwork (leaflet, outer pack, and label).

Reviewing the initial documentation and ensure its compliance with regulations for OTC, food supplements and Medical Device.

Keeping the internal company systems e,g Veeva and champs  accurate and most updated.

Submission of the relevant application to SFDA for the relevant process (new submission variation and renewal) and following up on the application status and addressing the SFDA inquiries.

Prepare and submit application to SFDA to get the approval for advertisement activity for OTC products and medical device.

 

 

 

Qualifications and skills

 

Essential

Bachelor degree

2-5 years’ experience in Regulatory Affairs in pharmaceutical company.

 

Preferred

Experience in food product registration.

Experience in medical device registration.