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Glossary > Regulatory Affairs Lead Manager
Role Purpose
This position provides leadership in developing
and implementing a regulatory strategy for the
company and leads to effort to ensure technology
products achieve timely country regulatory
approvals
In addition this position is responsible for
ensuring compliance of the research and product
development activities of the biotechnology
products program meet with all applicable
Government regulations of biotechnology crops.
Typical Work Activities
- Responsibilities include all phases of the
process for the import, interstate movement and
environmental release of regulated biotechnology
crops in the region
- Familiarity with the Regulatory Science data
requirements to support approvals for commercial
production of biotechnology crops.
- Organize
and coordinate the work of Regulatory
Affairs Managers located throughout the
region, ensuring efficient data development,
documentation, reporting and harmonized
approaches to Regulatory Affairs
submissions.
Educational Requirements
- PhD degree in molecular biology, plant biology,
horticulture or agronomy.
Knowledge, Skills and Experience
- 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.
- Demonstrated ability to effectively interact
with different Regulatory Authorities and
presenting eloquent arguments in the critical
area of plant biotechnology.
- Ability to work in or with a multinational team
- Well developed leadership and project management
abilities and a creative, motivated team player.
- Cross-functional communication, interpersonal,
oral and written communication skills.
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