Global Regulatory System Integration Specialist
Your tasks and responsibilities
Bayer U.S. LLC seeks a Global Regulatory System Integration Specialist to work in Whippany, NJ.
The primary responsibilities of this role, Global Regulatory System Integration Specialist, are to:
- serve as global specialist responsible for developing and managing the interaction, integration and interoperability projects of global regulatory systems of our pharmaceutical products.
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
bachelor's degree (or foreign equivalent) in Chemical Engineering, Regulatory Science or related field plus five (5) years of post-baccalaureate and progressively responsible experience in a related position.
- developing and managing the interaction, integration and interoperability projects of global regulatory systems and processes;
- strong knowledge of eCTD and hands-on experience of global regulatory document and submission management systems;
- collaborating proactively with cross function teams including document management, submission management, information management, and master data management, etc.;
- monitoring regulatory intelligence topics related to computerized systems from health authorities globally and developing competitive strategy;
- eCTD 4.0 and RPS as well as eCTD version upgrade and implementation;
- GxP relevant computerized systems testing and problem-solving for electronic submission publishing, review, validation and archiving, in accordance with the GxP relevant Quality Assurance procedures;
- conducting training for internal cross-functional professional staff, on document authoring, document management systems, and international workflow processes; and
- developing and maintaining operational guidelines and best practices in accordance with various health authority regulations and global standard operating procedures.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.