REGULATORY AFFAIRS SPECIALIST

Responsabilities

·  Identify regulatory requirements in new and existing markets and assess the impact of such requirements on manufacturing, product development and the business.

·  Manage product registration globally via various activities including but not limited to preparing and procuring documentation, documenting and tracking progress of new registrations and re-registrations in each market. Ensure that progress is in line with the company’s targets.

·  Identify areas in the process where speed and efficiency of product registration can be improved, provide upper management with options to do so.

·  Keep abreast of regulatory changes or proposed changes that may impact product formulation, product manufacture and/ or product registration.

·  Build and foster strong working relationships with contacts at governmental agencies Facilitate the exchange of documents and technical conversations to support registration.

·  Notify immediately of awareness of any regulatory requests, including safety labelling changes, urgent safety restriction requests, as well as external inspections.

·  Keep abreast of emerging legislation and highlight the potential impact on the business.

·  Ensure compliance with statutory local, regional and international corporate régulations

Profil:

Higher diploma and experience in regulatory affairs or regulatory compliance/quality assurance role.
Significant knowledge of internationanal and local Regulatory processes and preferably regulatory compliance experience within a manufacturing environment.
Creative self-starter capable of working autonomously and developing this role.
Good problem-solving skills and the ability to work to tight deadlines.
Thorough attention to detail and high standards of accuracy.

Fluent in English, French (speaking, reading and writing)

Minimimum of 2-3 years of work experience in the pharmaceutical industry or similar sector is considered an advantage