1. Accelerate regulatory approvals for biotech products: have in-depth understanding on key challenges for all pending and pipeline products, lead regulatory outreach strategy development and regulatory message/talking point drafting, and identify key external stakeholders by closely partnering with relevant internal functions/groups.
2. Defense Bayer’s “License to operate by partnering with both internal and external stakeholders to advocate science based and predictable regulatory environment, and push for timely acceptance of new methods and new technologies
3. Obtain regulatory approvals of new biotech products from Korea regulatory agencies to secure global commercialization. Maintain regulatory approvals for approved traits in Korea to ensure smooth Ag trade for Bayer products;
* Lead product specific submission/data strategy development and develop high quality dossiers
* Develop strategy on the responses to the questions and lead internal alignment on critical questions with colleagues in Global.
* Defense regulatory data and positioning by interacting with key external stakeholders
* Develop and provide input on study protocols for both internal and government required regulatory studies to ensure science-based, well-compliance study design in order to ensure timely approvals.
4. Monitor and influence local regulatory requirement and regulatory environment. Develop cross-crop/product submission/data plan and regulatory strategy by working with internal stakeholders.
1. Education: BS, MS or Ph.D in Science preferred biochemistry, molecular biology, plant biology, protein chemistry, agronomy, plant breeding, chemistry or related discipline, Ph.D is preferred.
2. Experience: Minimum of 8 years of regulatory affairs or relevant experiences in agricultural, biotechnology, crop protection, pharmaceutical or related scientific based industry.
3. Excellent written and oral language skill in both local language and English to convey complex ideas in a clear, precise, and logical manner.
4. Strong technical background to understand the regulatory data and in-depth understanding on political and/or regulatory environment;