Grcy-0, Regulatory Affairs Cluster Manag

1 week ago

القاهرة, Egypt Merck Group Full time

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

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 Associate manager / Manager 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 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.
- French and English language proficiency is a must

**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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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