Universidad Complutense de Madrid

Regulatory Affairs Intern en Mylan

Hatfield, England, United Kingdom

- Update/maintain SPPs in-line with current SOPs and guidance to support the release of finished product for approved Marketing Authorisations within the EU.- Ensure databases and systems are updated in-line with current SOPs and up-to-date information.- Prepare and submit simple variation applications to designated markets according to agreed company procedures and objectives. Store information in line with department guidelines to ensure effective retrieval.- Advise management of the status and progress of assigned duties identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects.- Assist Line Manager by supporting departmental initiatives as may be required.- Develop an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and liaison with Competent Authorities) and use this information to optimise departmental procedures and processes.- Support the submission of information via VERTIFY (EVMPD Team) to the Health Authorities for new entries and variations.

Marta Palomo