R Senior Specialist, Regulatory Affairs

About the job R Senior Specialist, Regulatory Affairs

Job Description

Responsibilities:

• The Senior Specialist is responsible for all Regulatory Affairs submission requirements for their assigned product portfolio as applicable. He/she is the regulatory contact with local stakeholders and headquarters (HQ) and is the direct contact for health authority submission specific topics.
• The Senior Specialist also acts as the regulatory relevant License Holder for the company (eg. License To Operate).
• The Senior Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and drug safety oversight.
• The Senior Specialist is also responsible for other activities (as delegated/assigned by their manager).
• Assists in developme...