Regulatory Affairs Compliance Specialist - Research Triangle Park, NC
November 18, 2020
Regulatory Affairs Compliance Specialist - Research Triangle Park, NC-2002692 We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, age, citizenship, color, religion, sex, marital status, national origin, disability status, gender identity or expression, protected veteran status, or any other characteristic protected by law.
At BASF , we create chemistry through the power of connected minds. By balancing economic success with environmental protection and social responsibility, we are building a more sustainable future through chemistry. As the world's leading chemical company, we help our customers in nearly every industry meet the current and future needs of society through science and innovation. We achieve this through our commitment to continuous improvement and operational excellence, which gives us the opportunity to set and deliver on ambitious, long-term goals.
We provide a challenging and rewarding work environment with a strong emphasis on process safety, as well as the safety of our employees and the communities we operate in and are always working to form the best team--especially from within, through an emphasis on lifelong learning and development. This allows for our employees to innovate and generate new ideas, put them into action, and gain insights from them to further advance our collective expertise.
And we are constantly striving to become an even better place to work. BASF has been recognized by Forbes Magazine in 2020 as one of America's Best Employers. We strongly support the spirit of collaboration through effectively involving team members and colleagues from other relevant units when developing and executing strategies and projects. Come join us on our journey to create solutions for a sustainable future!
Regulatory Affairs Compliance Specialist (2002692) - Research Triangle Park, NC
Where the Chemistry Happens...
We are seeking a professional like you to ensure license to operate with all US government regulations at country and state level for BASF seeds regulated materials, including movement and field trial activities, monitoring potential compliance breaches before matters become critical. In this role, you will be responsible for regulatory compliance and quality management for regulated field trials supporting Regulatory Science, Trait Research, Trait Development and Trait Introgression. You will also be responsible and accountable for planning, designing and implementing strategy for obtaining government approvals for import, movement and confined field trial activities at country and state level for BASF regulated seed materials.
Formula for Success: You Will...
Responsible for planning and implementing the submission strategy to ensure movement and field trials permits as per R&D and seed business timelines. Responsible for regulatory field compliance to limit corporate risk exposure by ensuring compliance with all governing regulations and requirements related to regulated activities. This position has country responsibilities but with influence in the global regulated seed field compliance program.
Prepare electronic and hardcopy Field Compliance Notebooks and compile and evaluate the data received from the Field Trial Research managers. Train and manage contractors for regulated field trial inspection program. Understand the requirements for regulated field trials and develop trainings to communicate the requirements to contractors.
Works closely with the Stewardship function to guarantee that company policy guidelines for handling of regulated materials in the field are aligned with government compliance requirements.
Establish and maintain 100% compliance in all country field trials in collaboration with key business personnel (Trait Research, Trait Development, Seeds Regulatory Science, among others) ensuring adequate resourcing, communication of technical information, compliance training, quality management execution, recognition programs, etc.
Participate with the Country/Region Compliance Team on the review and development of processes, procedures, and quality documents and ensure that the country compliance program is aligned as government permits with regional and global compliance program.
Create an inclusive environment which embraces and drives value from diversity. Establish and support a safety culture in which safety is number one priority. Establish and support a safety culture in which safety is number one priority.
Ensure seed Trait Research, Trait Development, Trait Introgression, Regulatory Science project timelines, where permits for import of regulated materials/seed are delivered in time for annual seeding activities without delays, contributing in this way to projects and new seed products development and/or registration
Manage internal and external electronic tools to submit applications and reports to the Authorities as required in the approval conditions. Archive and manage data storage in appropriate internal databases. Coordinate with Stewardship, Shipping logistics and Biosafety the documentation (construct lists, government approvals, labels, packing and handling instructions, etc) needed for import, movement and field releases and provide them to the appropriate stakeholders.
Qualifications - BASF recognizes institutions of Higher Education which are accredited by the Council for Higher Education Accreditation or equivalent
B.Sc. in Agronomy, Chemistry, Biology +7 years' experience in Ag Biotech R&D or Seed business M.Sc. in Agronomy, Chemistry, Biology +5 years' experience in Ag Biotech R&D or Seed business Ph.D. in Agronomy, Chemistry, Biology +2 years' experience in Ag Biotech R&D or Seed business
Expertise preferred in growing row crops in the field or greenhouse.
Expertise in permitting procedures for import, field research and compliance in the country.
Working knowledge of GM trait development processes including quality management systems.
Working with regulated GM seeds and related compliance and stewardship processes/programs
Good organization & planning skills and excellent communication abilities.
Experience working with multi-cultural teams in diverse working environments
The comprehension of country regulatory issues, requirements and guidelines for the movement and field release of regulated material is required plus the potential impact in the global landscape. Must be able to deal with fluctuating guidelines, policies and agency personnel that can make estimating regulatory approval timelines challenging.
Adding value to our customers begins with adding value to you. you@BASF is the suite of benefits, perks, programs and unique opportunities we offer to support you--the whole you--in all stages of your life and career. With you@BASF, you create your own chemistry.
The total rewards that you receive as a BASF employee go way beyond a paycheck. From competitive health and insurance plans, to robust retirement benefits that include company-matching contributions, to making sure you never stop learning, we believe investing in you is investing in our success. Working for a large, global organization, you'll have a chance to grow professionally and personally, expand your network and build a rewarding and dynamic career.
BASF provides interesting and challenging learning and development opportunities to help you make the most of your talents and your job.
Primary Location: US-NC-Research Triangle Park
Function: PRCO - Public Relations, Communication & Government Affairs
At BASF, we create chemistry – and have been doing so for 150 years. Our portfolio ranges from chemicals, plastics, performance products and crop protection products to oil and gas. As the world’s leading chemical company, we combine economic success with environmental protection and social responsibility. Through science and innovation, we enable our customers in nearly every industry to meet the current and future needs of society. Our products and solutions contribute to conserving resources, ensuring nutrition and improving quality of life. We have summed up this contribution in our corporate purpose: We create chemistry for a sustainable future.