Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Regulatory Documentation Specialist
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Regulatory Documentation Specialist, are to:
- Build all electronic and paper submissions via Bayer Crop Science (BCS) software tools (DDCT, DART) in close communication with regulatory affairs managers (RAMs) for submission to EPA and data requesting states; ensure high quality of submission package in regard of document formatting and indexing, including both pre consultation with BCS RMs and follow-up with EPA on submission adequacy and quality;
- Serve as the expert to collect data for various requests from the business or regulatory affairs like data compensation, litigations, divestments and transfers of assets projects;
- Manage department archives: storage and retrieval of archived Regulatory Affairs documents in compliance with BCS Records Retention Policy and EPA recordkeeping regulations;
- Send incoming approval documents from EPA and State Lead Agencies to appropriate RAMs via BRIDG;
- Manage Regulatory relevant Documents both electronic Confidential Statement of Formula (CSF) and Federal Pesticides Labels in their existing databases with equivalent metadata information and uploading of Adobe Acrobat files (scan originals of paper and convert to searchable PDF);
- Support the Documentation Lead in the development of training concepts and materials and deliver regular training session for regulatory related processes, systems and tools for the North America personnel in strong alignment with global resources;
- Facilitate the implementation of new IT tools and environments as a change coach;
- Provide consulting to Regulatory Affairs group on information and documentation problems both proactively and on demand;
- Identify and implement electronic solutions and processes to meet user needs and increase efficiency of department;
- Manage regulatory efforts in obtaining registration for production facilities, and the maintenance of those registrations;
- Serve as Company contact in this area with EPA’s Office of Compliance;
- Create and maintain records on annual production of pesticide products and maintain these reports in department database;
- Obtain and deactivate Company establishment numbers on demand;
- Act as Agent for selected non-U.S. suppliers to BCS;
- Ensure production facilities are compliant with U.S. regulatory requirements.
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:
- Bachelors Degree with a minimum of five years relevant scientific experience or Master of Science with minimum of two years of relevant experience or Ph.D. with relevant experience;
- Excellent records management skills and training;
- Sound understanding of record maintenance requirements and government recordkeeping processes;
- Computer literacy (including use of databases and other electronic documents management tools, word processing, and e-mail);
- Good communication and teaching skills;
- Highly-skilled at meeting deadlines and assessing/juggling shifting priorities in a rapid-pace environment;
- Must be able to work independently with minimal supervision;
- Essential are high standards of personal accuracy, initiative, a strong service orientation, effective oral and written communication skills good interpersonal skills.
- Information technology field experience.
Reference Code: 176974
Functional Area: Quality
Entry Level : Professional