Regulatory Affairs Manager m/f Job in Ingelheim 55218, Rheinland-Pfalz Germany
Are you seeking a new professional challenge at a pharmaceutical company which has achieved success at an international level and been named "best employer" several times?
Are you highly motivated and willing to take responsibility for interdisciplinary tasks within Global Regulatory Affairs?
If so, we can offer you the opportunity to use and advance your professional skills in a demanding international field of work.
Your tasks
- Creation and implementation of sound regulatory strategies as part of product development plans for international development products and strategic product maintenance optimisation initiatives
- Leading international regulatory teams for new development substances and strategic projects
- Coordination and initiation of interaction with health authorities, in cooperation with regional coordination centres or local regulatory departments
- Compilation of and driving EU regulatory maintenance, e.g. variation applications, follow up measure, PSURs and renewals
- Worldwide regulatory maintenance and compliance responsibility for marketed pharmaceutical products
- Contribution to individual working groups dealing with DRA systems and internal process improvements
- Support to the group leader and office head regarding specific projects and activities
Your ideal qualification
You should have a formal degree in medicine, pharmacy or life sciences (e.g. biology or chemistry) and at least 2 years or more industrial experience, preferentially in regulatory affairs.
Specific regulatory expertise in the indication area of oncology, immunology and virology as well as practical experience in handling European registration procedures and solid international regulatory knowledge and understanding of important regulatory authorities are necessary. The position requires in addition computer literacy.
You are committed, tenacious and you are able to work in a team environment, e. g. in international project teams. In addition you possess good interpersonal, organisational and excellent communication skills.
Due to the international nature of the tasks fluency in English is essential.
You will be based in Ingelheim near Frankfurt, Germany.
We can offer stimulating career development with a suitable remuneration and a benefits package.
If you are seeking opportunities to expand your professional horizon and your profile corresponds to the above, we look forward to hearing from you.
For further information please contact Anne Renkes, phone +49 (0) 61 32 / 77 64 42.
As a company without barriers we welcome applications from people with disabilities if they have the relevant qualifications.
We look forward to receiving your online application - please enter
the reference code 4003 2007 ING 10/11 2.