דרושים Regulatory Affairs Specialist / Sr. Regulatory Affairs Specialist בכל הארץ

About Freyr

Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance

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Why Freyr?

At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint to Warsaw, Poland, we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory service

Join Our Team:

If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr. Together, we can shape the future of regulatory solutions

📢 To Apply:

Please apply to this job post or you can visit our Careers page for more openings

Visit our Careers page at (https://www.freyrsolutions.com/careers/current-positions) to explore current job openings and submit your application. Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together!

Title : Regulatory Affairs Specialist / Sr. Regulatory Affairs Specialist

Experience : 5+ years in Medicinal Products Regulatory Affairs

Location: Saudi Arabia, Egypt

Reporting To: RRLs for APAC & MENA

Role Type: Operational / Individual Contributor

Position Summary:

This role ensures compliant regulatory execution across diverse geographies Middle East/North Africa. The consultant prepares HA-facing submissions, localizes regulatory content, and manages both electronic and paper-based workflows depending on HA maturity. Close collaboration with local agents and translation providers is essential.

Key Responsibilities:

· Compile and submit hybrid or full eCTD dossiers depending on market (e.g., MFDS, SFDA, ).

· Prepare Module 1 components tailored to each market’s requirement (PoAs, declarations, legalized annexes).

· Translate and validate SmPCs, PILs, and artwork in Arabic and others.

· Coordinate dispatch through local submission portals or physical courier with in-country agents.

· Respond to HA queries, validation reports, or deficiency letters with appropriate documentation.

· Maintain HA tracking systems, regulatory databases (RIMS), and internal logs with submission metadata.

· Ensure end-to-end alignment with client SOPs, HA procedural checklists, and archiving policies.

Technical & Functional Skills:

· Hands-on knowledge of SFDA (Saudi), and CAPA (Egypt).

· Flexibility to work with eCTD, PDF-based submissions, or paper dossiers depending on HA systems.

· Strong capability in handling legalized documentation workflows and admin dossier components.

· Experience with multi-script PI (Arabic).

· Familiarity with cross-border agent coordination and compliance with local dispatch rules.