Manager, Regulatory Affairs -Americas
Location: Research Traingle Park, North Carolina, USA BASF is proud to be an Affirmative Action and Equal Opportunity Employer.
DESCRIPTION
Throughout the 20th century, BASF has played a leading role in agriculture and nutrition. BASF Plant Science (BPS) has expanded on this legacy through the application of biotechnology to crop improvements in the areas of agronomic and feed quality traits, and selective applications in the food and industrial markets. BPS was founded in 1998 and is represented at seven sites in four countries. With this international network of expertise, BPS is especially well equipped to be a leader in plant biotechnology. BPS develops sustainable solutions for superior agricultural productivity, better and healthier nutrition and renewable resources. Leadership, creativity, teamwork and passion combined with our unique plant biotechnology expertise are the foundation for our success.
BASF Plant Science is seeking to appoint an innovative and highly experienced Regulatory Lead for North and South America who will be based at their site in Research Triangle Park (RTP), NC, U.S.A. The Regulatory Lead will be responsible for management of Regulatory Affairs and Compliance in the Americas and will report to the Director, Global Regulatory who is based in the USA. The position will lead the staff of Regulatory Affairs and Compliance Managers based in RTP, Brazil and Argentina. As BPS continues to develop biotech traits/crops for cultivation in the Americas, this functional responsibility is expected to increase over the next three years.
The Regulatory Lead will have regulatory responsibilities for BASF Plant Science's crop biotechnology products in the Americas as well as leadership and coordination responsibilities for regulatory initiatives in all countries in the Americas. Specifically, the position will be responsible for ensuring compliance of the research and product development activities of BASF Plant Science's crop biotechnology products program in the Americas with all applicable Government regulations of biotechnology crops. Responsibilities include all phases of the process for the import, interstate movement and environmental release of regulated biotechnology crops in the Americas. The position will also be responsible for all aspects of Regulatory Affairs in the Americas. He/she must be familiar with the Regulatory Science data requirements to support approvals for commercial production of biotechnology crops. In addition, the position will have a leadership role in coordinating the work of Regulatory Affairs Managers located throughout the Americas region, ensuring efficient data development, documentation, reporting and harmonized approaches to Regulatory Affairs submissions. He/she will provide a strategic overview for developing and implementing a regulatory strategy for BASF Plant Science's crop biotechnology products in the Americas region to achieve timely country regulatory approvals consistent with the overall objectives of the BASF Plant Science's crop biotechnology business. Additional responsibilities will be considered commensurate with experience. In all these aspects the Manager, Regulatory Americas will coordinate with the Director, Global Regulatory.
QUALIFICATIONS
BASF recognizes institutions of Higher Education which are accredited by the Council for Higher Education Accreditation or equivalent
REQUIRED:
- PhD degree in molecular biology, plant biology, horticulture or agronomy, with at least 8 years of professional experience in Plant Biotechnology and/or Agricultural related Regulatory Compliance / Regulatory Affairs, and demonstrated ability to achieve successful regulatory approval of an agricultural product. A Master's or Bachelor's degree in same with at least 12 years of experience in same would also be considered.
- Working experience with the U.S. regulations and policies covering the use of, agricultural products and familiar with agricultural products regulations in other countries in the Americas region.
- Demonstrated ability to effectively interact with different Regulatory Authorities and presenting eloquent arguments in the critical area of plant biotechnology.
- Strong intercultural orientation and interest in a multicultural environment.
- Ability to work in or with a multinational team
- Well developed leadership and project management abilities and be a creative, motivated team player.
- Cross-functional communication, interpersonal, oral and written communication skills.
- Ability to meet goals and to attain the desired results, often under time pressure and in a fast changing environment.
- Previous supervisory experience.
PREFERRED:
- Demonstrated ability to achieve successful regulatory approval of a biotech crop product
- Working experience with the U.S. regulations and policies covering the use of biotechnology crop plants, and familiar with crop biotechnology regulations in other countries in the Americas region
- Functional ability in Spanish/Portuguese
BASF recognizes Institutions of Higher Education that are accredited by the Council for Higher Education Accreditation or equivalent.
To apply for this position, please click on the link below or copy/paste it into your browser address bar :
https://basf.taleo.net/careersection/2/jobdetail.ftl?lang=en&job=109287 More positions from: BASF SE Posted from January 20, 2011 until July 20, 2011 SeedQuest reference number: 14053 |