Senior regional Regulatory Affairs Associate

6 days ago

Cairo, Cairo, Egypt STADA Emerging Markets Full time 120,000 - 240,000 per year

STADA is a leading manufacturer of high-quality pharmaceuticals. With a long-standing heritage rooted in pharmacies, we are perceived as a reliable and trustworthy partner since 1895. With our products we help people protect and regain a dignified and able life. With our proven Generics, we ensure that everyday health remains affordable.

At STADA, we follow our purpose of "Caring for People's Health as a Trusted Partner".

In pursuit of this purpose, we are committed to further accelerating the successful trajectory of our company. To our employees, we offer an attractive working environment in which they can develop personally.

We are currently recruiting for the position of Senior regional Regulatory Affairs Associate to be based in Cairo - Egypt.

Job description:

  1. Governance of dossiers' technical aspects based on the knowledge for existing & emerging regulations.
  2. Validate registration dossiers to ensure compliance with regulatory guidelines.
  3. Compile, Prepare, submit and acquire approval for registration dossiers supporting various regulatory activities including submission and maintenance of marketing authorization (new registration & renewal applications), submission of variations (Labelling & CMC), submission and maintenance of relevant licenses (to import, store and distribute medicinal products) across MENA markets.
  4. Maintain & archive technical documentation, databases or systems.
  5. Develop internal and external communication channels with different stakeholders to support regulatory projects.
  6. Provide needed regulatory support & advise to different departments: marketing, supply chain, commercial, medical, Pharmacovigilance…etc.
  7. Analyse, prepare and respond to queries raised by Health Authorities.
  8. Coordinate, create, translate & proofread packaging materials, product information leaflets and summary of product characteristics in local language as needed.
  9. Support development of Standard Operating Procedures (SOP), work instructions or policies.
  10. Ensure compliance with local health authorities' regulation, company policies & procedures.
  11. Maintain knowledge with company products.

Candidate profile:

  1. BSc degree in Medical or Pharmaceutical Science.
  2. Minimum 5 years' experience in Regulatory Affairs within Middle East North Africa region with significant depth within pharmaceutical & medical device industry.
  3. Knowledge with Health Authorities regulation across Middle East North Africa region.
  4. Fluency in written & verbal communication in Arabic & English languages.
  5. Computer literate & familiarity with computer-based information system & software.
  6. Strong communication, negotiation & Analytical Skills.
  7. Strong problem solving, Project & time management capabilities.

If you are ready for new challenges where you can make a difference for people's health, you have come to the right place. We are looking for people with great attitude and passion. The next step is yours, take a look at our open positions and become part of our global STADA team

Click here to view other open positions at STADA

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Please note that only successful candidates will be contacted.

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