Regulatory Affairs Professional

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

Required skills to have for the success of this role


* BS/MS in a scientific discipline


* A minimum of 5 years of regulatory affairs experience in the pharmaceutical industry.

Sterile injectable experience preferred.


* 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%

Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries.

As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing.

Our portfolio is crucial for clinical dec...