menarini

Menarini, Company Description: Menarini is one of Europe’s leading pharmaceutical and healthcare companies, with headquarters in Florence.
The company has achieved year on year growth by an emphasis on promoting leading edge products, and combining this with high quality service and technical support.

The Opportunity: We are looking for a French Africa Regulatory Affairs Specialist

· Regulatory Affairs Specialist – French Africa
· Location: Tunisia
· Area of responsibility: French Speaking Africa

Description And Aim
The French Africa Regulatory Affairs Specialist will manage the regulatory affairs operations /activities in French speaking Africa in order to support Menarini’s Business objectives in efficient ways and in compliance with the corporate legislation, the Regulatory Specialist will play critical role in the implementing the regulatory plans and working procedure of the Regional Regulatory department .The Regulatory Affairs Specialist will assist the French Africa Regulatory Affairs Manager in all regulatory relevant matters to execute the implementation of the regulatory strategy.

Main Responsibilities And Scope
• Execution of the planned and agreed registration plans for new products, major changes and life cycle management activities.
• Register and maintain registration of manufacturing sites and MAH registration where applicable
• Maintain product licenses in compliance with local regulations
• Communicate with the distributors in each of the markets to ensure the assigned regulatory activities are executed in line with the company regulatory objectives and in compliance with the local regulations and guidelines
• Support Regulatory, Quality and compliance activities
• Collaborate with Medical, Marketing, Supply Chain and any internal stakeholder and pro-actively ensure Regulatory input is provided in a timely manner.
• Establish and maintain good and trustworthy relationships with distributors, local Health authorities and pharma associations.
• Ensures Regulatory compliance of Product Artwork, labelling components and all promotional materials addressed to the market with the local regulation and code of practice.
• Ensure the business partners are aware of expected regulation changes that could impact Menarini products and advise higher management on appropriate course of action.
• Ensure all regulatory activities are conducted in line with the internal corporate SOPs and Working instructions
• Effective communication to key stakeholders of key issues that could impact regulatory strategies or the business
• Understand local regulations/codes and developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders.
• Provide regulatory intelligence knowledge to support the development and implementation of regulatory and business plans and objectives.
• Ensure proper archiving for all related documents. Maintain Register and Documentum regulatory systems always up to date.
• Report any regulatory risks to the line manager
• Involved in corporate audits, finding analysis and remediation plan implementation

Company Procedure & Follow-Up Process
• Comply with the data integrity policy and commitment.
• Monitoring and analysing the processes and ensuring that the necessary actions are taken for improvement.
• Maintaining, backing up and archiving (or ensuring that they are made) all records under her/his responsibility as determined and destroying the records under his/her responsibility as determined when the retention period expires.
• Fulfilling and implementing responsibilities mentioned in all procedures of the company.
• The process managed in accordance with Company Procedures; s/he is responsible for ensuring that the activities of the inputs and outputs are correct, the resources are sufficient, the process is monitored, the records are kept, the performance is measured and, when necessary, reporting on these issues.

Required Qualifications
Education Level: at least Bachelor degree
Education Faculty / Department: Pharmacy or Equivalent
Work Experience:
• Minimum 3 year of experience in Regulatory Affairs is required
• Previous experience in Pharma multinational is required
• Previous experience in English speaking Africa is preferable
Technical Knowledge: Proficient with applicable and regulatory database and compliance software. Proficient with Microsoft Office Suite or similar software.
Foreign Language: French / English

Competencies & Skills
• Excellent spoken and written communication skills
• Excellent presentation and interpersonal skills
• Able to articulate complex Regulatory Affairs issues /Problems
• Excellent Organization and leadership management skills and ability to work on a number of projects within strict timelines
• Excellent analytical and strategic thinking skills.
• Proactively identify regulatory risk and manage impact of regulatory changes on the business
• Strong teamwork collaboration
• Excellent Negotiation skills

Comment postuler
Send resume to ›

Ville › Tunis
Nom / Entreprise › Menarini
Tel / Fax › 70039225