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.
Regulatory Affairs Manager
MAIN TASKS AND RESPONSIBILITIES
- Prepare and update registration plan to achieve regulatory milestones such as Registration Trial Permit (RTP), registrations submission & approval based on product development plan, and communicate with relevant colleagues from other functions of BCS China and Asian Pacific Regulatory Affairs team in order to obtain the study reports and package dossiers from local & global team on time
- Compile registration dossiers following local data requirements strictly, to ensure the high quality of dossiers submitted by BCS China and the success of achievements
- Ensure timely submission & follow-up closely in the registration processes
- Prepare answers to the questions raised by authority regarding responsible products during registration evaluation
- Manage confidentiality of dossiers strictly following company regulations
- Circulate new registration certificate/new labels approved by Chinese regulatory authority in order to support the relevant activities of other functions
- Communicate with regulatory authority on general regulatory affair issues in suitable conditions to enhance and improve BCS image of profession & expertise
WHO YOU ARE
- Master degree of Science or equivalent education background in an area related to Crop Protection business
- Mid. to long-term working experience (more than 5 years) in R&D based Multinational Companies in relevant industries
- Good English knowledge (both written and spoken); strong local language skills to facilitate translation of global documents into local submissions
- Good at managing regulatory affairs and good understanding of scientific as well as political dimensions
- Strong organization, planning, dossier compilation skills. Strategy thinking. Excellent communication abilities focusing on concise summarizing of technical material, reporting on developments and negotiation with government personnel (understanding objections and overcoming them)
- Able to overcome complexity, diplomacy, ability to negotiate, optimism, practical solution-finding and persistence to deal effectively with lengthy project review periods, diversity of personalities, potentially conflicting government mandates and cultural differences amongst team members
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 208481
Functional Area: 注册事务