Natural Scientist as Deputy Teamlead – Regulatory Affairs (m/f/d)
Hello, we at AMW have been operating as a pharmaceutical company for over 15 years. In Warngau, south of Munich, over 150 employees produce and develop medical innovations for international partners and patients worldwide. Our core competence is smart biodegradable implants for the treatment of cancerous tumors.
Our daily business is similarly smart, with drive and a spirit of discovery: a modern working environment, respectful cooperation, short decision-making processes and great views of the nearby mountains and for your own development are just some of the plus points that await you here.
Discover it for yourself!
This is what you bring forward:
- Whenever approvals are involved, your expertise is in demand – in your new role you will represent our company in all regulatory matters and play an active role in the development and implementation of approval strategies.
- You will take over the deputy management of our registration team, with which you will support and advise international customers in the maintenance and preservation of existing registrations as well as new registrations in Europe, Asia and Latin America.
- Within this framework, you will develop and coordinate new approval applications, process deficiency notices and maintain existing approvals so that our products can continue to improve treatments for people all over the world.
- In addition, you will support the internal and external preparation/review of pharmaceutical quality documentation, administrative documents and other marketing authorization documents (eCTDs, PSURs, RMPs, etc.).
- You will work closely with our specialist departments (development, quality control, production, quality assurance and business development) to bring innovative projects to a successful conclusion.
Your recipe for success:
- Completed studies (ideally with a doctorate) in a natural science
(e.g. biology, pharmacy or chemistry) - Ideally several years of professional experience in admissions and initial experience in team leadership
- Extensive expertise in the German, European and non-European pharmaceutical legal environment (LATAM, MENA, APAC) and knowledge of the relevant approval procedures
- A big plus: Know-how in the regulatory environment of medical devices (especially with regard to Notified Body Opinions)
- On a personal level, you have strong communication skills in German and English, excellent interpersonal skills and a high degree of team spirit and organizational skills.
Smart working conditions: We have!
- Flexible flexitime system
- 32 days vacation
- Professional security and socially effective work in a fast-growing pharmaceutical company with an international focus
- A feel-good working environment: flat hierarchies, short decision-making processes and a culture of appreciation
- Individual further training offers
- Company pension scheme
- Job wheel
- An E-Gym Wellpass membership (sports and leisure activities)
- Fresh fruit and discounted, healthy fresh food at our lunch table
- Bicycle parking spaces
- A location with high recreational value – beyond the nearby mountains, e.g. thanks to the many cultural offerings in Munich and the surrounding area
Ready to enrich us?
Then we still need your application (with cover letter, CV, last reference), which you can send quickly and easily by e-mail to bewerbungen@a-m-w.eu please send it to us.
If you have any questions in advance, please contact our Senior Manager HR Michael Marx on 08024 470999-52.
You can find our current data protection conditions at https://a-m-w.eu/datenschutz/.
Your further route to us:
If you fit in with us, a team call is your next step towards us. A second interview takes place directly on site. And step 3 leads you – if everyone is still convinced – to your AMW starting position.