Regulatory Affairs Specialist

Research Triangle Park, NC, United States
Apr 16, 2018
Required Education
Bachelors Degree
Position Type
Full time
Your tasks and responsibilities

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

  • Manage the state regulatory activities necessary to support and maintain the business, including state registrations of Section 3,
    Section 24(c), Section 2(ee), Section 18, Experimental Use Product

    (EUP), etc. for crop, environmental science and/or certain bioscience products. Influence/negotiate with State Lead Agencies to obtain timely approval of pending petitions, applications and actions;
  • Interact with and influence internal functional technical experts to ensure the necessary scientific data, studies, documentation, interpretations and information are available in a timely manner for data reviewing States (e.g. California, New York). In association with technical experts, business, product safety, state affairs and others, formulate regulatory strategies to obtain favorable registrations and to defend existing product registrations;
  • Compile and submit required data and documents necessary for registration across all States. Maintain regulatory database tracking systems for products. Forecast the cost of state registration fees annually, track and provide updates and adjustments as needed. Process payment of state registration fees, including new product registration fees and annual state renewal fees and submit state renewals / licenses for BAYER products with appropriate documentation;
  • Provide asset/business teams with interpretation and/or confirmation of the State regulatory requirements of various State Lead Agencies.
    Maintain compliance by interpreting and evaluating state registration requirements as they apply to Bayer products;
  • Manage development of State acceptable labels and ensure compliance with state regulations by working with business teams and label specialists during the label development and submission process (federal and state);
  • Maintain current awareness of and assure company compliance with evolving state registration and label requirements. Convey critical knowledge, especially that relating to assigned products, to relevant managers, appropriate Bayer scientists, and others to alleviate or reduce regulatory impacts and costs. Facilitate favorable regulatory outcomes through establishing appropriate internal and external meetings and facilitating positive interactions with external State
    Lead Agency personnel;
  • Provide regulatory support and service to internal customers (e.g.
    Business and Product managers, Customer Service, Supply Chain, etc.). As well as external customers. Respond to customer inquiries (internal and external) and state regulatory agency inquiries for registration / regulatory information;
  • Interact with industry colleagues and represent Bayer to external audiences as required to advance Bayer's position and strategies. Lead industry association efforts on procedural issues and participate on technical issue teams.
  • Regulatory approval represents the license to operate and State approval is the license to sell. This position is crucial in obtaining state regulatory approval of Bayer pesticide products. This position is responsible for renewing existing product registrations in all 50 states, the District of Columbia and Puerto Rico. This position is critical to obtaining timely new sales opportunities for Bayer products, through the procurement of new product registrations, and to maintaining existing sales by meeting State renewal fee requirements and keeping accurate records. Incumbent will be responsible for state registration fees of approximately $1.5 M annually;
  • State Registration ensures that the company avoids fines and/or other penalties due to non-compliance with State laws and regulations.

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 4 years of minimum relevant experience, or, a Master's degree with 2 years of minimum relevant experience, or, a PhD with minimum years of relevant regulatory experience;
  • Known within the network of key SLA's with demonstrated ability to achieve and maintain state registrations;
  • Capable of providing strategic direction and timeline estimates to asset teams based on policies, procedures and regulations;
  • Knowledge of the State and Federal EPA regulatory processes;
  • Scientific knowledge of applicable area(s) to the state regulatory process;
  • Strong negotiating, influencing, and problem solving skills;
  • Ability to work well with others and in a multifunctional team environment;
  • Innovative in areas where little precedent exists;
  • Particiaptes and supports meeting s of interdisciplinary workgroups to addres project specific issues;
  • Contributes in organziational regulatory compliance.

Preferred Qualifications:

  • Experience with ALSTAR and other industry-based software programs;
  • Experience with submission and approval of registrations in all US states and the District of Columbia;
  • Experience in special registrations (e.g. FIFRA Section 24(c), Section 2(ee), Section Section18, Section 5 (Experimental Use Permits));
  • Knowledge of the data requirements for data-reviewing states and experience in compiling and submitting dossiers to SLA's.

*Domestic relocation assistance may be provided.

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. 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. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

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.

Country: United States
Location: NC-Research Triangle Park, NC-Raleigh