Senior Regulatory Affairs Associate

7 days ago

Cairo, Egypt Johnson & Johnson Full time

**Job Function**:
Regulatory Affairs Group
**Job Sub Function**:
Regulatory Affairs
**Job Category**:
Professional
**All Job Posting Locations**:
Cairo, Egypt

**About Innovative Medicine**

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

**We are searching for the best talent for a Senior Regulatory Affairs Associate to be in Cairo, Egypt.**

**Essential Job Duties and Responsibilities**:
- Coordinate the preparation, review, submission and follow-up of regulatory files that are properly formatted and in compliance with local regulations.
- Execute regulatory plans and manage timelines to achieve the stated goals.
- Respond to inquiries from the different HAs.
- Maintain archiving of correspondences and other records of all filings and interactions with regulatory authorities.
- Strategic alignment on the preliminary submission of new products with the global team & internal stakeholders.
- Develop & maintain relationships with Health Authorities & other relevant organizations.
- Ensure that all regulatory activities are conducted in compliance with relevant laws & regulations as well as J&J guidelines.
- Alignment with the different stakeholders ex.supply chain, marketing,commercial ,market access, etc
- Coordinate and execute submission of products label updates.
- Responsible for updating the database and support Janssen systems.
- Comply with J&J guidelines and local laws & regulations.
- Handling RA activities (Renewal, Label updates, Registration analysis or any other RA activities)

**Minimum Qualification**
- Minimally basic degree in Pharmacy.
- Min 5 years of Regulatory experience & working in MNCs.
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
- Excellent computer proficiency
- Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
- Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
- Handling RA activities (Renewal, Label updates, Registration analysis or any other RA activities)
- Demonstrated ability to manage multiple assignments.
- Desire to work as part of an effective, cohesive group.

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