Regulatory Affairs Manager

For Johnson & Johnson Saudi Arabia, we are currently recruiting a Regulatory Affairs Manager - GCC.
In this role you are responsible for the following:
• Act as Regulatory Cluster Value team (RA CVT) member and as RA Expert for the corresponding Therapeutic
Area:
RA CVT member
• Provide strategic and valuable RA input into CVT and Value excellence teams.
• Active participation in business development processes under regulatory perspective across GCC region to maximize products access to patients.
• Understand Business model and strategy drivers.
• Cooperation and partnership horizontally with commercial, MAF, and other functions (Govern. Affairs, BQ, Human Resources, Logistics ), as well as vertically with IBVTs and Brand Teams to shape the CVT strategy and create added value.
• Act as regulatory representative on project teams and provide advice on specific projects contributing to the development of project plans and target product profiles.
TA Expert
• Execute and/or facilitate regulatory plans and manage timelines to achieve the stated goals.
• Interpret the regulatory framework, including GCC trends, aiming to communicate on time the stakeholders working for providing documents or taking actions for needed submissions.
• 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.
d. 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 their requests and relevant information from LOCs.
e. Active participation in regional/global meetings, ensuring regulatory excellence and proposing the best scenery for each GCC country to anticipate the submissions and approvals as well as future needs.
f. Maintain archiving and appropriate databases and systems:
• Ensure electronic and the paper tracking of regulatory activities and Marketing authorizations lifecycle.
• Ensure archiving of regulatory dossiers.
• Populate and update appropriate J&J;databases as per J&J;processes.
• 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.
• 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 review packaging material to ensure compliance with the Marketing Authorization and Follow- up implementation with the Quality team.
• Ensure adopting the latest GCC guidelines in all submissions and ensure our shared sheets are always updated in a timely manner.
• Provide regulatory support to all company functions upon request.
• Review, as per request, educational and promotional material to ensure compliance with the marketing authorization.
• Compliance Responsibilities
• Report Adverse Event & product quality complaints as per J&J;Pharmacovigilance guidelines.
• Review SOPs when needed in accordance with the applicable responsibilities scope.
• Comply with local laws & HCBI guidelines, Foreign Corrupt Practices Act (FCPA), Policy on Business Conduct (PBC).
• Ensure HCC and legal requirements are fully understood.
• Ensure inspection readiness with respect to personal training compliance, and availability of recent CV and individualized Job Description
• Line Management Responsibilities
• Manage and direct RA specialist by providing coaching and feedback, if applicable.
• Direct RA specialist activities to ensure that specified timelines and reporting requirements are met.
Qualifications
• Pharmacist
• Good knowledge of regulatory requirements, HA regulations & guidelines in GCC countries
• Good communication and presentation skills, both verbal and written
• Detailed oriented
• Able to manage multiple assignments and work well under pressure
• Strategic and business-driven
• Highly organized
• Desire to work as part of an effective, cohesive group
• Good level in English
Primary Location
Saudi Arabia-Ar Riyad-Riyadh-
Organization
Johnson & Johnson Middle East FZ-LLC Branch Legal Entity (8613)
Job Function
Regulatory Affairs

https://www.naukrigulf.com/manager-regulatory-affairs-jobs-in-riyadh-saudi-arabia-in-johnson-and-johnson-2-to-3-years-n-cd-10002042-jid-160222501308