Job Responsibilities:

Regulatory Planning 
• Collaborate with Partners to ensure timely and clear dossier requirements are provided to Egypt Affiliate during submission planning
• Liaise cross-functionally to agree on submission strategy for new products, new indications, renewals and source changes/adds
• Ensures rapid and timely approval on of new drugs, biologics, food supplements and/or medical devices and continued approved status of marketed drugs or medical devices
• Ensure submission plans are created and maintained in Abbott Regulatory IT tools
• Facilitate implementation of the Regulatory Plan in alignment with the business plans
• Monitor impact of changing regulations on submission strategies
• Negotiate with regulatory authorities during the development and review process to ensure submission approval
• Maintain importation plan and align cross functionally on any possible risks

Post market
• Oversee processes involved with maintaining annual licenses, registrations, listings and patent information
• Ensure compliance with product post marketing approval requirements
• Review and approve advertising and promotional items to ensure regulatory compliance
            
Dossier Management 
• Work cross-functionally to obtain all required submission documents and ensure timely responses to Regulatory Authority requests received
• Voice Region and Partner perspective and requirements to global regulatory contacts. Coordinate feedback to ensure documents are as required by Partner and use regulatory expertise to provide creative solutions/alternatives in cases where Abbott is unable to meet requirements
• Ensure provision of submission documents as per agreed timelines
• Ensure archiving of electronic copies of submission packages
• Document submission plans and follow-up on progress of submission/timelines with assigned Partner(s) and periodically review with Partner’s performance metrics
• Serve as affiliate regulatory point person for queries from the business or global functions (GRA, Quality, Supply Chain, Manufacturing) Regulatory Compliance
• Ensure data maintenance and data integrity of internal Regulatory IT tools with defined compliance metrics
• Ensure implementation of local quality system in line with the global quality system and local regulations
• Support internal and external audits / assessments / self-inspections in collaboration with Quality personnel
• Implement corrective/preventive actions as appropriate
• Raise awareness to relevant functions on compliance issues and initiatives

Labelling 
• Perform the function of Primary Affiliate Labelling Responsible Person (ALRP), ensuring that Product Information complies with Abbott Core Data Sheet
• Follow global and local labelling procedures to review Proposed Labelling for exceptions to Core Labelling and ensure all such exceptions are documented
• Ensure timely creation of labelling projects in Agile and liaise with Medical, commercial, quality, Supply Chain and Opx to ensure new/revised labelling available in line with the business plan

Process Improvement
• Ensure alignment and implementation of internal regulatory initiatives 
• Identify and present option for risk mitigation to decision makers

Personal and Professional Development 
• Knowledge and understanding of local and regional regulations and local, regional and global regulatory procedures
• Attend appropriate external symposia, workshops or conferences to develop technical expertise

Experience/ Education Required:
• Bachelor's degree or equivalent in a relevant scientific subject.
• At least 5-7 years industry related experience in Regulatory Affairs.

• Minimum 3 years in a multinational background is a must.
• Team working skills with special focus on results. 
• Ability to adapt to challenging situations.
• Demonstrated good computer/IT skills.
• Good knowledge of written and spoken English & Arabic. 

Other Information/Additional Preferences: 
• Analytical, problem solving and negotiation skills. 
• Good communication skills. 
• Project management skills. 
• Strong planning and priority setting. 
• Dynamic and flexible.
• Problem solver.
• Good capability to establish positive networking both internally. 
• Strong knowledge of quality systems.