GRCY-0, Regulatory Affairs Senior Specialist - French speaker

Posté 05 juil. 2022

Cairo, Egypt - Egypt

Demander un identifiant 251750

Détails

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


The Regulatory Affairs Senior Specialist in MEAR RA Hub is responsible for

  • Defining and implementing regulatory strategies and submissions in support of new and existing products. As well as Plans and manages all assigned regulatory activities accordance with implemented regulations in North Africa & other African markets.
  • The timely response to Health Authorities’ requests related to regulatory submissions.
  • Timely completion of regulatory projects and submission of documentation to regulatory agencies.
  • Ensure product labelling and advertising materials for all products comply with product dossiers and relevant regulations.
  • Represents Regulatory Affairs on cross-functional project teams to support planning, development, implementation and execution of marketing strategies and ensures alignment with project business goals relating to combination product chemistry, manufacturing and controls (CMC) as well as product labeling issues on a local and global basis.
  • Assist the Regional and Global Regulatory team in analyzing country product data, regulatory legislation and providing country specific information.
  • Responsible for compliance with post-market approval regulatory obligations and maintenance of licenses/ authorizations for existing products, including review/approval of internal specifications, evaluation of changes in product or processes to determine regulatory impact, and identification of Process Excellence improvements.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html

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