Regulatory Authority Partner

Job Description

SummaryPerforms the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. Works independently within guidelines and policies, receives minimal guidance. Acts as a resource for colleagues with less experience and provides functional guidance.Your Responsibilities

• Customize the global registration dossiers as required by the Egyptian Health Authorities / Plan country specific requests
• Customize renewal files for local submissions, ensuring support for missing docs until approval/handling trouble shooting with junior stakeholders and team leads at EDA
• Customize the global variation file, following up and tracking the variations application until approval
• Submit the labeling updates in light of either global or local Health Authority requests
• Manage the process of issuance of annual / complementary Importation plans for Roche Products on timely manner
• Manage the process of issuance of special import permits/licenses for non-registered products
• Handle third party logistics provider activities, attend inspection visits when needed to ensure proper processes
• Plan authority?s lab analysis requirements to ensure smooth process
• Oversight batches pre-evaluation process, with help of regulatory messenger to determine inspection needs for every inspection visit
• Handle EDA release process for imported products portfolio including inspection visits, analysis process at NODCAR / NORCB
• Communicate with shortage department, provide monthly stock reports and request fast track release process when needed to maintain healthy stocks on patient level
• Align with internal stakeholders (supply, quality and business) on monthly / quarterly priorities to secure sales and ensure release activities are done at optimum time thus maintaining products supply versus the required demands
• Manage the promotional materials submissions with different stakeholders to ensure submission to EDA as per the regulations, and follow up until approved and released by EDA
• Maintain good relationship with junior stakeholders and team lead at Egyptian Drug Authority
• Liaise with Pricing and Regulatory leads regarding response to Egyptian Drug Authorities requests
• Collect competition intelligent regulatory data to support marketing strategies
• Maintain efficient regulatory archive and systems compliance
• Mentor or train other junior team members in their day-to-day activities
• Perform other duties assigned by the Regulatory lead as and when the need arises
• Attend/complete all requisite on-line and F2F trainings (Role specific, Safety responsibility and Compliance) within specified time limit
• Identify, collect and immediately report all safety related information on Roche product to Local Safety responsible as per Roche requirements and local regulations
• Adhere to company (both local and global) policies and procedures at all times, including Health and Safety requirements

• You hold a University degree in Pharmacy, Pharmaceutical Sciences, or any relevant education
• You have a minimum of 5 years of relevant work experience in Regulatory Affairs
• You are IT savvy and can easily adopt to the use of digital tools/applications
• You possess strong time management, project management, and prioritizing skills
• You have strong stakeholder management skills
• You are detail oriented and at the same time able to keep the high level overview
• You are very proactive and have a strong sense of responsibility
• You have strong communication and presentation skills
• You have team working, problem solving and strategic thinking skills
• You have strong English and Arabic communication skills both spoken and written

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