RA Specialist

We are seeking a highly skilled RA Specialist to join our team at the Pini Group. As an RA Specialist, you will play a crucial role in ensuring the regulatory compliance of our products and services.

Your primary responsibility will be to support the elaboration, establishment, and application of the RA standard at all sites. This includes helping to ensure internal standards are maintained in regulatory compliance, consulting with local RAC teams on CMC and regulatory strategies, guiding operators through the issuance and submission of regulatory documents, and providing hands-on support in implementing and applying corporate standards.

You will also be responsible for coordinating regulatory activities across various groups during CMC process development and chairing the corporate RAC organization as part of the Corporate Quality Organization.