Regulatory Affairs - Intern

Job description

Main Job Duties/Responsibilities:

·  Co-ordinate dossier and briefing package preparations accordingly to the plans ( new registrations and maintainace) and monitoring dossiers up to implementation.
·  Ensure optimal support to key stakeholders to deliver on-time high quality dossiers in compliance with Health Authority requirements.
·  Liaise with HA contacts persons, organizing and preparing HA meeting and attending as appropriate.
·  Manage the maintainace of a product portfolio.
·  Accountable for keeping the database updated on a timely basis for portfolio he/she is in charge of.
·  Provide support and communication information on products to other functions.
·  In Liaison with his/her manager . can be involved in activities such as shortage , DHCP.
·  support the consolidation and provision of regulatory expertise and giving input about requirements and needs.
·  Follow Regulatory changes, Competitors status and assess potential impact on daily activities and project strategy

Knowledge /Education:

·  Undergraduate degree in Pharmacy and/or related life science discipline is required.

Professional Knowledge/Skills:

·  Negotiation and communication skills.
·  organization skills and high accuracy in documentation.
·  High sense of Urgency.
·  Knowledge of new decrees new guidelines.
·  Problem Solving skills.
·  Interpersonal Skills

Role is an internship position for a 6 months duration

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.