Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else.
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Regulatory Affairs Specialist KSA
KSA, Riyadh
Job Description
RA Specialist will fulfill the local regulatory activities to maintain & keep the RA portfolio compliant for KSA ( 70 % ) and rest of ME markets ( 30%) . He / she will support RA manager on operational RA submissions to allow the RA managers in UAE & KSA to focus on critical projects Relfydess & Nemluvio . In addition , RA manager in KSA needs to focus on enhancing external engagement with Health authority & local trade association that is identified as a major gap currently. RA Specialist will ensure business continuity and serve as a back up for RA manager in KSA for RA in addition to serving as a back up for QA & PV , considering that RA , QA & PV are mandatory functions to be always available on site .Provide strategic and operational RA support for Saudi to ensure on time renewal, maintenance , variations of existing & new products for IA, TD, DS including mandatory regulatory. It is critical to maintain momentum to ensure compliance to constantly evolving SFDA guidelines
Duties & Responsibilities
Manage the entire registration process in ensuring approvals of new products and amendments to products
Develop and execute registration strategy in close partnership with Global RA & local RA manager
Stay abreast of - and ensure compliance with - the continuously evolving (complex & country specific) regulatory framework in KSA & rest of ME markets
Ensure compliance with, and maintenance of, existing product licenses.
Ensure high quality and timely submissions, support in enhancing regulatory intelligence , create & maintain database for simplifying local RA processes of record retention , regulatory submission tracking
Ensure that progress of applications and changes to registered details are communicated to local and global stakeholders, as appropriate
Manage in-house regulatory files, documentation and Corporate electronic databases. With the LE set up in Saudi the responsibilities & accountability of RA manager in front of Saudi HA ( SFDA ) have increased requiring more time & focus from RA manager to engage with external stakeholders & ensure compliance at all time for all regulated TD,IA,DS portfolio. RA specialist is critical to ensure compliance to ongoing RA activities , serve as back up for RA / QA/PV and allow RA to focus on critical submissions ongoing & to be made for Relfydess & Nemluvio to enable timely registrations . RA specialist will also support projects that need improvement in process enhancement & simplification tools for all ME markets , such as tracking tools , data management & also internalize some of the RA activities that are currently outsourced such as eCTD preparation in a phased manner
Minimum Requirements
Pharmacist degree/Bachelor degree in Pharmaceutical sciences.
Saudi Arabia national and MOH licensed pharmacist
Minimum 4-5 years’ experience in a similar Regulatory affairs role in the field of prescription medicinal products and medical devices in Saudi Arabia & UAE
In-depth understanding of the pharmaceutical industry within Saudi Arabia, and strong connections with SFDA will be preferred
Quality experience & fair knowledge of Pharmacovigilance preferred.
Computer literate, familiar with Computer based information systems, and new
Electronic documentation systems.
Fluency in written and verbal English and Arabic
What we offer in return
You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
You will receive a competitive compensation package with bonus structure and extended benefit package.
You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take accountability.
Next Step
Please apply with an English language CV.
If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
The next step is a virtual conversation with the hiring manager.
The final step is a panel conversation with the extended team.
