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Job Description:

The Near East Regulatory Affairs team is seeking a talented Associate Regulatory Affairs professional to support our mission of accelerating patient access to innovative healthcare solutions. The role offers broad exposure to regulatory strategy, portfolio management, external stakeholder engagement, and cross-functional collaboration across multiple markets. You will join a high-performing team recognized for its commitment to excellence, innovation, and patient-focused impact.

Essential Job Duties and Responsibilities

Act as Associate Regulatory Affairs Professional for NE Countries within specific therapeutic areas: Hematology-PAH-CNS

Extended - CVT member

• Provide strategic and valuable RA input into CVT and Value excellence teams, whenever needed.
• Understand Business model and strategy drivers.
• Cooperation and partnership horizontally with commercial, MAF and other functions (Govern. Affairs, BQ, Human Resources, Logistics…)
• Act as regulatory representative on project teams and provide advice on specific projects contributing to the development of project plans and target product profiles; whenever needed

TA Specialist

• Execute regulatory plans and manage timelines to achieve the stated goals.
• b. 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; MA transfer and distributor changes…) 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:
  • Receive, assess completeness/relevance, track and archive core dossiers received from international groups.
  • Forward all relevant information/data from and in accordance with international groups to LOCs.
  • 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:
  • Ensure electronic and paper tracking of regulatory activities and Marketing authorizations lifecycle.
  • Ensure archiving of regulatory dossiers.
  • Update, maintain and use regulatory databases, tracking tables and information systems.
•   Manage submissions related to concerned TAs (Hematology-PAH-CNS) in scope of MEWA pack project, RLC project etc..

Daily business & product supply Support:

• Provide guidance to peers within J&J and other external partners.
• Coordinate preparation of responses to specific Health authorities’ requests and support, as appropriate, preparation of the relevant regulatory dossiers (e.g., Importation requests, NPP, clinical trials application, etc.).
• Develop and create and review packaging material to ensure compliance with the Marketing Authorization and Follow-up implementation with the Quality team.
• Provide regulatory support to all company functions upon request.
• Review, as per request, promotional material to ensure compliance with the marketing authorization. Where applicable (e.g., No local regulatory responsible), archive promotional material and maintain a formal list of valid material.
• Comply with local laws & HCBI guidelines, Foreign Corrupt Practices Act (FCPA), Policy on Business Conduct (PBC).

Compliance Responsibilities

• Ensure safety reporting requirements (timely AE/PQC reporting) 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 HCC and legal requirements (Fair Market Value, Transfer of Value rules, Promotional Materials rules) are fully understood, appropriately managed and, where applicable, complied 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

Required Skills:

Preferred Skills: