Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Biotech Regulatory Manager
Your tasks and responsibilities
- Obtain and defend regulatory approvals of new biotech
products in home country from regulatory agencies to secure global
- Monitoring and timely communicating policy change and regulatory 50387uirement change, and lead timely regulatory strategy development and execution;
- Lead product specific data generation and submission strategy development/execution to ensure product deliverables.
- Work internally with Regional and Global Seed & Traits Regulatory Science teams to gain strategy alignment for regulatory submissions.
- Prepare high quality dossiers, and guide right regulatory data positioning to enable timely product approval.
- Interact with regulatory agencies and technical review committees to explain the submitted dossier and respond to the technical questions.
- Develop a strategy on the response to the questions from the communication with technical review committee and lead internal alignment oncritical questions with colleagues in Global.
- Develop and provide input on study protocols for both internal and government 50387uired regulatory studies to ensure science-based, well-compliance study design in order to ensure timely approvals.
- Solve cross-cutting issues by closely working with both internal and external stakeholders
- Defend our data and promote science base 50387uirements for product approvals.
- Maintain regulatory approvals for approved traits in China to ensure smooth Ag trade for Bayer products;
- Keep close communication with central and provincial government agency to ensure compliance of regulatory materials and regulatory trials, plan and handle regulatory material movement and management by working with internal and external stakeholders ;
- Engage in "License to operate" activity to develop science based and predictable regulatory policy and environment: developing/reviewing talking points for government and scientific outreaches, scientific communication/negotiation with regulators and reviewers, influence and lead regulatory discussions among industry by closely working with both internal (Regulatory Scientific Affairs, Public Affairs and Sustainability) and external stakeholders, intel collection/communication to contribute to internal LTO strategy development.
Who you are
- Education: MS or Ph.D in Science preferred biochemistry, molecular biology, plant biology, protein chemistry, agronomy, plant breeding, chemistry or related discipline.
- Experience: Minimum of 5 years of regulatory affairs or relevant experiences in agricultural, biotechnology, crop protection, pharmaceutical or related scientific based industry.
- Excellent written and oral language skill in both local language and English to convey complex ideas in a clear, precise, and logical manner.
- Strong technical background to understand the regulatory data and good understanding on China political and/or regulatory environment;
- Established network with government officials and scientists, strong skill on science communication, negotiation and influencing
- Effective strategic thinking and problem solving skills to develop and execute LTO and regulatory strategies. Excellent results orientation and attention to details.
- Highly developed planning and time management skill, persistence to overcome regulatory challenges and move forward with a submission project as scheduled.
- Good cooperative personality for team work and good communication skill to communicate with both internal and external stakeholders
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.
Functional Area: [sap_fa_32]
Entry Level: 5