Regulatory Affairs Officer

Besins Healthcare

Key Responsibilities:

• Acts as responsible Regulatory Team member for assigned regulatory projects.
• Preparation and submit Life-Cycle Maintenance regulatory submissions for Africa (English and French Speaking).
• Prepares and/or reviews regulatory documentation for National applications in line with assigned timelines.
• May support on some R&D regulatory projects.
• Actively participates and employs effective communication practices with internal stakeholder (CMC, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, and Globally based Regional Regulatory affairs team
• Understands the Scope of Work, timelines and deliverables for a given project.
• Prepare status reports and metrics for assigned projects.
• Perform assigned work according to current best good regulatory practice/guidelines in compliance with current legislation.
• Any other duties as assigned by your manager.
• Learn, develop, and train.

_Technical Skills/ Experience_

• >4-5 years pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Africa, Middle East, Asia (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions)-Europe/Turkey experience is and advantage.
• Preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling operations.
• Experience of GCC markets/ICH guidelines/MHRA guidelines
• Experience of emerging markets / international RoW markets and regulatory filings.
• Quality control review of technical/ regulatory documents.
• Understanding of Regulatory strategy and determination of documentation requirements. Compliance with SOPs, Change controls and regulatory best practices.
• Publishing: eCTD and or NEES.
• Pharmaceutical artwork review and sign-off.
• Project management experience - an advantage.
• Experience of Women s and/or Men s healthcare an advantage

_Soft Skills_

• Ability to work to tight timelines and manage peaks in workload.
• Good team player with internationally based colleagues in Global Pharmaceutical Affairs team.
• Positive can-do attitude in growing company with expanding range of therapeutic product range.
• Good negotiating skills and the ability to identify and resolve issues with external stakeholders.
• Excellent verbal and written communication skills.
• Excellent computer skills e.g. Word, Excel, data and document management systems.
• Cultural awareness for global ways of working.
• Able to act as a mentor to junior colleagues and to assist in their training and development as appropriate.
• Desire to grow regulatory operational and regulatory strategy experience.
• Languages: Speaking & Writing French is a Must- Fluent Arabic/English Required as well.

_Minimum required education and experience_

• Degree in Pharmacy or life science-related degree plus at least 4-5 year s relevant human pharmaceutical experience with focus on filing and lifecycle maintenance of marketed products in Middle East/ Africa/Asia