COE Regulatory Manager

JOB PURPOSE

The AMEE RA COE Country Manager will report to ME Arabic Speaking Countries COE

Cluster RA Head and will lead a team of AMEE RA COE Country Associates.

To achieve success it is critical that the The AMEE RA COE Country Manager:

• will lead a group of COE Regulatory Associates in a country.
• will be responsible for the management of the post-approval changes and regulatory compliance of a portfolio of marketed products in one or several countries.

KEY RESULTS / ACCOUNTABILITIES

1. Startegic management of the regulatory compliance of the marketed product portfolio

• Manage and monitor the regulatory compliance of the Sanofi marketed product portfolio in Egypt & Sudan
• According to the country regulatory requirements and planning, assess, coordinate and contribute to the preparation of ready- to- submit regulatory dossiers for the below :

-Labeling, CMC, administrative and renewal /annual report

-Site registration, GMPc renewals

-Packaging and Artworking

-Tender

-Any type of response documents to the Health Authorities questions by interacting with the relevant stakeholders (BU region regulatory, GRA, RSO local medical, local Pharmacovigilance department etc.) and monitoring of dossiers dispatch up to submission.

• Ensure regulatory compliance with products overall strategies and Health authorities country requirements evolution
• Ensure tender preparation if regulatory dossiers is needed
• Be compliant with all internal and external requirements, procedures and tools,
• Foster an environment/culture of learning and sharing of best practice within the team

2. Develop and maintain a good working relationship with internal and external stakeholders

• be a business partner for the Country regulatory teams
• be a business partner for Global CMC&Devices, Global Labeling, RSOs
• represent the regulatory position to senior management as needed

1.3. Ensure the overall implementation of goals and strategies of the group

• Ensure the harmonization of ways of working as part of the leadership team of the COE Region.
• Implement in timely manner , country plannings for dispatch and ensure alignment between COE activities and Regional BU/Country activities via “mutually agreed roles and responsibility sharing docs” and dispatch KPIs

2.4. Serve as the line manager for the staff of the COE country associates

• Serve as the line manager for the staff of the COE country associates.
• Serve as a coach and mentor to the staff and establish objectives and development goals for the team

5. People Leadership

• Performance manages the team through setting and reviewing priorities. Provides appropriate and timely feedback about performance and coaches team members to help them achieve their goals
• Supports the professional and career development of the team by identifying the skills and competencies that employees need for their current and prospective roles and provide opportunities to learn and practice new skills
• Leads the building of a motivated and engaged team through the use of formal and informal recognition, regular communications and the encouragement of cooperation between individuals and teams

6. Maintain Compliance

• Abide by the requirements of the internal Code of Ethics including but not restricted to maintaining high professional standards of conduct in line with the Company procedure with a duty of care to the reputation of the Company

7. Ethical Leadership

• Takes personal accountability to use personal experience and knowledge, as well as the training and tools provided by Sanofi, to maintain a good kno