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 & Drug Safety Animal Health
1. Managing the Regulatory Affairs & Drug safety Team in order to achieve the timely submission of high quality applications to comply with the requirements of both areas of the dpt. Ensure required training and learningcourses to the collaborators to improve abilities and capabilites to better perform their tasks.
2. Promote Pharmacovigilance training to AH employees
3. Ensure Regulatory compliance according to corresponding legislation and internal regulations including promotional material
4. Contribute actively to the design and assessment of local and global regulatory strategy options with HQ and Business Group.
5. Ensure technical / legal support regarding regulatory and pharmacovigilance issues.
6. Collaboration with the differnt Departments of the company
7. Open and transparent communication with the local authority (national and regional)
8. Local SOP writing, approval and implementation applicable to the department, in line with Global SOPs and EU legisilation.
9. Active participant in country / region networks.
Who you are
1. University degree or equivalent in pharmacy, chemistry, biological sciences or medicine, preferably Ph.D., M.D., Pharm.D. orequivalent.
2. Three to five years experience in managing successfully registration projects and direct contact with regulatory agencies.
3. Active participation in meetings organised by regulatory authorities, industry associations and professional organisations (national or regional) for several years.
4. Detailed understanding of structure, operating procedures and policies of the national agencies.
5. Basic understanding of structure, operating procedures and policies of the Regional and national agencies in other member states.
6. Legal knowledge both domestic and Regional law.
7. Detailed knowledge of drug development process
8. High degree of accuracy and reliability
9. Fluent English
10. Ability to communicate effectively, with proven negotiating skills, convincing presentation skills
11. Analytical skills • Project Management skills
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.
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: 65484
Functional Area: Regulatory Affairs
Entry Level : Professional