Regulatory Affairs Officer - Zentiva

Job description

Regulatory Affairs Officer - Zentiva

Reporting to the Regulatory Affairs Manager, the regulatory affairs officer:

·  Is responsible for the preparation, distribution and control of registration documentation required for regulatory submissions expeditiously and to high standards to ensure that marketing authorisations are obtained and maintained in line with the company’s requirements.
·  Contributes to timely communication of safety information to Regulatory Authorities, Healthcare Professionals and patients.
·  Provides input into plans for product development, commercialisation and discontinuation / transfer at a local and Corporate level.
·  Contributes to ensuring the company provides an uninterrupted supply of product to the market that is in compliance with the licensed particulars.
·  Works proactively with team members of the local and corporate business to ensure project needs are met compliantly within agreed timelines.

Required qualifications:

·  A degree or professional qualification in science, preferably a life science, and preferably some experience in Regulatory Affairs. Additional experience in the pharmaceutical industry or a related field would be an advantage.
·  Familiar with the pharmaceutical research and development process, and capable of critically reviewing and integrating scientific information from a variety of disciplines.
·  Administratively well-organised, have attention to detail, possess strong written and oral communication skills and be able to manage multiple priorities.
·  Training in regulatory requirements should continue, both externally through courses and meetings, and internally, to maintain an understanding of current regulatory requirements and issues
·  Self-motivated and able to demonstrate cross-functional collaborative working

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life