Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Product Submissions and Registration 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. Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Regulatory Affairs Professional - KSA & Gulf. This hybrid work position will be located in Cairo, Egypt.

Essential Job Duties and Responsibilities:

• Execute regulatory plans and manage timelines to achieve the stated goals.
• Coordinate the preparation, review, submission, Tracking and follow-up of regulatory files (including but not limited to: New MA dossiers, renewals, variations, response to questions) that are properly formatted and in compliance with local regulations.
• Prepare local/administrative sections where no local regulatory responsible is designated according to country specific requirements.
• Act as liaison and main contact between LOCs and international groups:
• I. Receive, assess completeness/relevance, track and archive core dossiers received from international groups.
• II. Forward all relevant information/data from and in accordance with international group LOCs.
• III. Keep international groups informed of regulatory statuses in LOCs and forward to them requests and relevant information from LOCs.
• Maintain archiving and appropriate databases and systems:
• I. Ensure electronic and paper tracking of regulatory activities and Marketing authorizations lifecycle.
• II. Ensure archiving of regulatory dossiers.
• III. Populate and update appropriate J&J databases as per J&J processes.
• IV. Update, maintain and use regulatory databases, tracking tables and information systems.
• Daily business & product supply Support:
• Provide guidance to peers within J&J and other external partners.
• Assess the registration status for the manufacturing sites for assigned products across GCC
• Support in planned life cycle management for assigned products across GCC
• d. Update our systems and tools to leverage digital
• Comply with local laws & GCC guidelines
• Communicate with GCC disturbers to assess products and sites registration and renewal status to allocate requirements
• Communicate with internal stakeholders to provide all the local requirements for regulatory activities.

Compliance Responsibilities:

• Ensure safety reporting requirements as set out in company policies and SOPs (Standard Operating Procedures) are met and, where applicable, appropriately managed when planning projects, developing materials, executing projects, and contracting vendors
• Ensure inspection readiness with respect to personal training compliance, and availability of recent CV and individualized Job Description

Special requirements: knowledge of GCC regulations is desirable

Desired Candidate Profile

Pharmacist or Scientific Degree

3 years experience in Regulatory Affairs with Regional Responsibility

Good knowledge of regulatory requirements, HA regulations & guidelines in GCC Countries

Good communication and presentation skills, both verbal and written

Demonstrated ability to manage multiple assignments

Anticipation and planning skills

Highly organized

Ability to work cross-functionally

Desire to work as part of an effective, cohesive group

Good level in English and Arabic languages.

Skilled in Outlook and Microsoft office applications