Regulatory Affairs Manager, Egypt - Cairo, مصر - AstraZeneca

AstraZeneca
AstraZeneca
شركة تم التحقق منها
Cairo, مصر

منذ أسبوع

Fatima Mahmoud

تم النشر بواسطة:

Fatima Mahmoud

beBee Recruiter
وصف
The job holder will be responsible for performing activities in drug regulatory affairs, he/ she will:

Core Accountabilities

Regulatory:


  • Ensure timely, accurate and compliant labelling translations and artwork preparation for assigned products
  • Recommend changes for labelling, manufacturing, and marketing for regulatory compliance
  • Monitor and improve tracking / control systems
  • Foster an environment/culture of learning and sharing of best practices within the team
  • Develop, maintain, and support cleaning of products databases
  • Maintain and update regulatory files and records as required; ensure appropriate archiving of all relevant documentation to be in line with applicable internal company standards. Also, support process improvements and implementation of best practices especially for archiving and other technical systems
  • Follow up and answer EDA queries in timely manner till final approvals are granted and shared with all interested parties
  • Build and maintain strong rapport with external stakeholders

Good Regulatory Practices (GRP):


  • Work in compliance with the global and local SOPs and EDA regulations
  • Comply with the GRP KPIs with ability to identify and flag risks
  • Ensure completion of the needed trainings for new procedures

Qualifications / Experience needed:


  • Bachelor's degree in Pharmacy
  • Strong experience in regulatory affairs
  • Good understanding of regulatory agency philosophies, culture, and developing trends in the regulatory environment
  • Knowledge of drug development practice, rules, regulations and guidelines
  • Networking internally and externally to learn in advance about new trends or changes impacting the Regulatory, Medical and overall Business strategy
  • Team player, capable of effectively collaborating with the cross functional team
  • Strong organizational skills
  • Advanced degree is a "Plus"
  • Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines is desirable

Why AstraZeneca?

  • At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare._
المزيد من الوظائف من AstraZeneca
انظر جميع وظائف AstraZeneca