Category
Legal
Publish Date
Sunday 30-05-2021
Country
Egypt
Gender
any
Years Of Experience
6 - 9 Years
Salary
Negotiable
A multinational company located in Giza is hiring a Regional Regulatory Manager
Job Description:
- Coordinate & manage post approval submissions including Marketing Authorization Transfer (MAT) for the group of assigned markets
- Develop & manage post approval including MAT plan, strategy, timelines and execution in alignment and partnering with key stakeholders (i.e. PGS, Markets, Clusters, Labeling team, Submissions Management, CMC, PV, Quality) to ensure a submission ready dossier for the assigned market(s).
- Liaise with CMC Product Strategists. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in regulations for assigned markets
- Ensure a submission planning and forecasting tool is utilized to update timelines when necessary, communicate changes to relevant partners
- Capable of authoring some local submission components in relevant databases
- Ensure submission packages are reviewed against local CMC requirements for consistency and completeness
Qualifications:
- Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life science.
- MSc, MBA or PhD may be an advantage
- Excellent Arabic and English languages
- Experience in regulatory affairs, preferably in human medicines - minimum 5 years of experience.
- Experience in people management will be an advantage
- Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.
- Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards.
