Sr Regulatory Affairs Documentation Specialist

Your Tasks And Responsibilities

The primary responsibilities of this role, Sr Regulatory Affairs Documentation Specialist, are to:

• Compiles compliant US submission packages via Bayer Crop Science (BCS) software tools and creates the published output for electronic or paper submissions to Environmental Protection Agency (EPA) and data-requesting states;
• Builds high-quality submission packages with regard to document formatting and indexing;
• Performs technical quality control on submission packages ensuring submission build and publishing output are according to federal and state requirements;
• Collaborates closely with Regulatory Affairs Managers (RAMs) for submissions to EPA and data requesting states;
• Supports customers, and provides consulting and guidance to Regulatory Affairs on documentation and information management;
• Supports requests from the business or Regulatory Affairs to collect data for compensation, litigations, divestments and transfers of assets projects;
• Collaborates with external vendors for hard-copy dossier management;
• Maintains a high standard of accuracy and timeliness to support the Business Objectives to achieve registrations according to timeline;
• Identifies and supports the implementation of process improvements, electronic solutions, and new processes to meet user needs and increase the efficiency of the department (such as Smart Dossiers);
• Leads medium to high-complexity cross-functional projects/process improvement initiatives;
• Manages regulatory efforts in obtaining registration for production facilities, and the maintenance of those registrations;
• Serves as Company contact in this area with EPA s Office of Compliance;
• Creates and maintains records on the annual production of pesticide products and maintains these reports in department database;
• Obtains and deactivates Company establishment numbers on demand;
• Acts as Agent for selected non-U.S. suppliers to BCS;
• Ensures production facilities are compliant with U.S. regulatory requirements;
• Develops training concepts & materials and delivers training for regulatory-related processes, systems, and tools for the US and Canada in strong alignment with global resources;
• Provides mentoring to colleagues within the area of expertise;
• Shares relevant regulatory knowledge, insights and experience with colleagues.

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:

Required qualifications:

• Bachelor's degree with two years of relevant experience Master's degree with minimum relevant experience;
• Demonstrates extensive knowledge and understanding of regulatory requirements for building and publishing electronic submissions; as well as data content and formatting requirements;
• Demonstrates extensive knowledge and understanding of regulatory domain, agricultural industry and competitive landscape;
• Must have extensive experience with Document management systems as well as Document creation and editing tools;
• Demonstrates extensive knowledge and understanding of regulatory requirements for building and publishing electronic submissions; as well as data content and formatting requirements;
• Demonstrates extensive knowledge and understanding of regulatory domain, agricultural industry and competitive landscape;
• Must have extensive experience with Document Management Systems as well as Document Creation and E diting tool skills;
• Highly skilled at identifying/recognizing potential compliance issues and proactively proposing solutions to resolve;
• Demonstrates ability to proactively escalate any timeline concerns, risks and issues that may delay/impact assignments and engage appropriate stakeholders to manage outcomes;
• Demonstrates excellent verbal and written communication skills with ability to effectively communicate at multiple levels in the organization;
• Ability to maintain open communication with stakeholders and builds sustainable relationships;
• Highly skilled at leveraging Data and Technology to deliver performance improvements and gain efficiencies;
• Demonstrates ability to prioritize workload and reassess shifting priorities in a rapid-pace environment to meet deadlines;
• Expert at time management, meeting deadlines and assessing/juggling shifting priorities in a rapid-pace environment;
• Excellent attention to detail and organizational skills;
• Highly skilled at problem-solving and proactively taking steps to mitigate risk;
• Demonstrates ability to lead multiple cross-functional projects;
• Able to reduce complexity within area of responsibility;
• Skilled at developing training materials and conducting training on processes, systems and tools;
• May represent BCS on certain industry task forces;
• Ability to mentor/coach junior colleagues;
• May represent RA in meetings (internally & externally) with senior management and peers assignments are a combination of operational & tactical in nature as well as providing input on strategic submission management issues;
• Must be able to work independently with minimal supervision.

Preferred qualifications:

• Relevant experience in an agricultural and/or regulatory domain preferred;
• Degrees preferably in agriculture, physical science, or natural science Knowledge & Experience: Qualification & Competencies;
• Relevant experience in an agricultural and/or regulatory domain preferred.

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.

If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice.

IMPORTANT NOTE for POTENTIAL US CANDIDATES: Bayer expects its employees to be fully vaccinated against COVID-19. Bayer active employees are also expected to disclose their vaccination status and if fully vaccinated, provide proof of vaccination status to Occupational Medicine. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, Bayer employees are also required to comply with state, local and customer requirements.

Division: Crop Science Reference Code 629281

Functional Area: Regulatory Affairs Location: United States : Missouri : Chesterfield

Employment Type: Regular Position Grade: M07

Contact Us

Address Telephone E-Mail

Creve Coeur, MO +1 888-473-1001, option #5 [email protected]

63167