Regulatory Affairs Professional

Siemens Healthineers

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Analyzes the requirements and prepares product related regulatory submissions. Collection, preparation and assembly of documentation required for various submissions to the US FDA that include but not limited to the following: Promotional materials, ANDA supplements, Annual Reports, Field Alert Reports, Adverse Event Reporting, Information Requests, external audit responses, etc. Responsible for supporting cross-functional activities pertaining to regulatory meetings, including the development of briefing documents and conduct of meeting rehearsals. Process product complaints, including conducting the investigation and writing the final report. Interacts with the Regulatory Project Manager and other project team members to ensure the timely preparation and receipt of information required for regulatory submissions. Proactively identify potential regulatory issues and recommend solutions to Regulatory Affairs management. Support business partners submissions as applicable Drives priorities and key issues as defined by regulatory management. Conversant and able to influence colleagues in regulatory strategies and compliance issues Educates internal stakeholders on implications of regulations. Develops timeline for responding to inquiries from regulatory agencies and ensures issues are addressed in a timely manner. Identifies and appropriately communicates potential risks

Requirements

BS/MS in a scientific discipline
A minimum of 5 years of regulatory affairs experience in the pharmaceutical industry.
A minimum of 2 years US FDA pharmacovigilance experience
Excellent communications skills (written and verbal)
Excellent planning, organizational and prioritizing skills
Meticulous attention to detail and accuracy
Ability to coordinate information from cross-functional disciplines
Working collaboratively with internal and external stakeholders
High standard of professional ethics, integrity and trust
Able to effectively multi-task
Flexible in responding to changing project priorities
Willing to travel up to 10%

Nice To Haves

Sterile injectable experience preferred.

Responsibilities

Analyzes the requirements and prepares product related regulatory submissions.
Collection, preparation and assembly of documentation required for various submissions to the US FDA that include but not limited to the following: Promotional materials, ANDA supplements, Annual Reports, Field Alert Reports, Adverse Event Reporting, Information Requests, external audit responses, etc.
Responsible for supporting cross-functional activities pertaining to regulatory meetings, including the development of briefing documents and conduct of meeting rehearsals.
Process product complaints, including conducting the investigation and writing the final report.
Interacts with the Regulatory Project Manager and other project team members to ensure the timely preparation and receipt of information required for regulatory submissions.
Proactively identify potential regulatory issues and recommend solutions to Regulatory Affairs management.
Support business partners submissions as applicable
Drives priorities and key issues as defined by regulatory management.
Conversant and able to influence colleagues in regulatory strategies and compliance issues
Educates internal stakeholders on implications of regulations.
Develops timeline for responding to inquiries from regulatory agencies and ensures issues are addressed in a timely manner.
Identifies and appropriately communicates potential risks