Description de l'annonce:

Rôle 

The Regulatory Affairs Country Associate will be responsible of managing the regulatory strategy and the post-approval changes dossier to Health Authorities in line with local regulations and planning set up by Global/Regional BU/Country Regulatory team.

Responsibilities

-   According to the country regulatory requirements and planning , prepare , assess , coordinate and contribute to the submission of regulatory dossier : New drug applications , Labeling , CMC , administrative , Site registration , Tender.

-  Responsible for managing the regulatory strategy.

-   Ensure regulatory compliance with products overall strategies and health authorities country requirements evolution

-  Provide support and communicating information on products to other functions

-   Be compliant with all internal and external requirements, procedures

-  Manage activities such as shortages , DHPC , B/R reevaluation.

-  Review and validate at country level promotional material with marketing and medical in line with Global strategies and policies

-  Accountable for keeping the databases updated on a timely basis for portfolio

-  Contribute to the set up of local regulatory SOPs.

-  Implement in timely manner all submissions and ensure alignment with country activities.

-  Maintain a good working relationship with internal and external stakeholders, be a business partner for the CHC organization/Country COE regulatory team.

-  Foster an environment/culture of learning and sharing of best practice within the team

- Prepare assess coordinate and contribute to the submission of  regulatory dossier for product and site registration in Libya 

Job Requirements and  Competencies

-  Education : PhD in Pharmacy

-  Comprehensive Knowledge and operational expertise of the EU/US and international regulations.

-  Excellent knowledge of Tunisian pharmaceutical regulations and requierement , Health related regulations.

-  Ability to work with multifunctional and multicultural teams in a matrix organization

-  Ability to act as a Business Partner

-  Ability to communicate effectively and efficiently with other functional departments in the business

-  Good relationship ability

-  Ability to resolve issues and proactivity

- Good Organizational Skills