Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Join our team now at Siemens Healthineers as Regulatory Affairs Professional
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Regulatory Affairs Professional, you will be responsible for:
- Collection, preparation and assembly of documentation required for various submissions to relevant Regulatory Authorities (FDA, MHRA, etc.)
- Regulatory submissions include but are not limited to the following: Promotional Material (OPDP), 483 responses, ANDA supplements, Annual Reports, Field Alert Reports, Adverse Event Reporting, etc.
- Process product complaints including conducting the investigation and writing the final report.
- Responsible for supporting cross-functional activities pertaining to regulatory meetings, including the development of briefing documents and conduct of meeting rehearsals.
- Proactively identifies potential regulatory issues and recommends solutions to Regulatory Affairs management.
- Participate in or assist senior regulatory associates in development of regulatory submissions within assigned products.
- Interacts with other project team members to ensure the timely preparation and receipt of information required for regulatory submissions.
- Interacts with internal and external partners as necessary to support product development.
- Support business partners (drug sponsors) with drug application submissions
- 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.
- Supports the preparation of responses to complex questions and comments from regulatory agencies.
- Develops timeline for responding to inquiries from regulatory agencies and ensures issues are addressed in a timely manner.
- Identifies and appropriately communicates potential risks
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers
- You have completed studies in a science/engineering-based program and have several years of relevant experience in Regulatory Affairs and/or Chemistry and Manufacturing Controls (CMC) in the pharmaceutical industry.
- General understanding of PET Drug cGMP regulations
- Prior product development experience (participation in non-clinical or CMC IND /NDA filing) experience desired.
- Experience with aNDA and NDA annual reports, supplements and other related FDA submissions is desirable. Experience with adverse event reporting and promotional material review is a plus.
- You have good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook)
- Willingness to travel and flexibility is expected
- You have very good writing and presentation skills in the customer (internal and external) environment and you show team orientation, communication skills and customer orientation
Required skills to have for the success of this role
- BS/MS in a scientific discipline
- Experience in Drug Manufacturing/Distribution/Pharmacy
- Excellent communications skills (written and verbal)
- Ability to review and interpret regulations
- High standard of professional ethics, integrity and trust
- Excellent planning, organizational and prioritizing skills
- Strong interpersonal /group skills; capable of working collaboratively with colleagues in all functions
- Attention to detail and accuracy
- Able to effectively multi-task
- Ability to coordinate information from cross-functional disciplines
- Flexible in responding to changing project priorities
- Willing to travel up to 10%
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Organization: Siemens Healthineers
Company: PETNET Solutions, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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