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. Based out of Warngau (South of Munich), our team of >150 highly talented people develops, manufactures and commercializes medical innovation for international partners and patients all over the world. 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.
Join us and find out 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.
In return, we offer smart benefits
- Flexible flexitime system
- 32 days vacation
- An exciting job with impact to improves patients’ health within a rapidly growing, international pharmaceutical company
- A friendly work environment with flat hierarchy, quick decision processes, and a great company culture based on mutual respect and appreciation
- Personalized career development programs
- Company supported pension scheme
- Job bike
- An E-Gym Wellpass membership (sports and leisure activities)
- An assortment of fresh fruit and discounts on fresh, healthy lunch meals
- Bicycle parking spaces
- An attractive location in greater Munich with plenty of recreational opportunities in beautiful nature close to the Alps, together with a rich cultural choice and excellent infrastructure for (international) travel.
Ready to make a difference?
If so, we would like to hear from you! Simply email us your application (including cover letter, resume, and most recent references) to bewerbungen@a-m-w.eu.
If you have any questions in advance, please contact our business support HR Ms. Stefanie Lang on 08024 470999-24.
Our current privacy policy can be found at https://a-m-w.eu/datenschutz/.
Your further route to us:
If you meet the requirements, our next step will be a call in Microsoft Teams. A second follow-up interview will be scheduled on-site if you (and we) feel it’s a good fit. And finally, step three (if all parties are on board) will be your AMW starting date.