Regulatory Affairs Manager (m/f/d)

A M W; Deutschland; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading bio-pharmaceutical company in Germany is seeking a Regulatory Coordinator to manage approval processes for innovative medical products. The ideal candidate will have a degree in a related field, project management experience, and strong communication skills. This role offers flexible hours, a supportive environment, and the opportunity to impact patient health in an international setting.

Leistungen

Flexible flexitime system

32 days vacation

Company supported pension scheme

Job bike

EGYM Wellpass membership

Discounts on healthy meals

Qualifikationen

• Educational background in medicine, pharmacy or related.
• Professional experience in pharmaceutical/biotechnology project management.
• Business fluent in English (C1 level).

Aufgaben

• Coordinate approval processes for medical innovations.
• Compile data into approval-relevant reports.
• Maintain communication with stakeholders regarding approvals.

Kenntnisse

Communication confidence

Decision-making skills

Proactive working style

Team spirit

Ausbildung

Completed studies in medicine, pharmacy, natural sciences, health management or a related field

License to practice as a pharmacist, ideally with a doctorate

Jobbeschreibung

Greetings from AMW, a fast-growing bio-pharmaceutical company that’s been thriving for more than 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 strength lies in smart drug delivery systems, such as biodegradable implants for sustainable treatment of cancer tumours.

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 prospects for your own development are just some of the plus points that await you here.

Join us and find out for yourself!

How you’ll make a positive impact

• In this key position, you will coordinate the approval processes (MRP/DCP, renewals, change notifications) for a large number of medical innovations and also maintain our regulatory database.
• You will assume direct product responsibility, manage the corresponding local approval projects and familiarize yourself intensively with the background (development and optimization history) of the products.
• You will independently compile existing data from various departments into approval-relevant reports or eCTD dossier sections and create the necessary documents independently if required.
• You will ensure approval-relevant communication with customers and specialist departments and support the specialist departments involved in the processing and documentation of approval-related changes and deviations.
• In addition, you will establish and maintain a document management system for admissions and play a key role in improving our department’s administrative processes.

Your recipe for success

• Completed studies in medicine, pharmacy, natural sciences, health management or a related field or a license to practice as a pharmacist, ideally with a doctorate and/or further training in drug approval
• Professional experience in pharmaceutical/biotechnology project management, preferably with knowledge of administrative and quality requirements in LATAM, MENA and CIS countries
• Business fluent in written and spoken English (C1)
• Communication confidence and strong decision-making skills
• With a confident and proactive way of working, team spirit and an interest in working independently, you will fit in perfectly with us.

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
• Company supported pension scheme
• Job bike
• EGYM Wellpass membership for sport and leisure activities
• An assortment of fresh fruit and discounts on fresh, healthy lunch meals
• 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?

Then we still need your application (with cover letter, CV, last reference), which you can send quickly and easily by e-mail to [e-mail]

You can find our current data protection conditions at https://amw-pharmaceuticals.com/datenschutz/.

If you have any questions in advance, please contact our Senior HR Manager Johann Walser on 08024 470999-104.

Your route forward:

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.

AMW GmbH
Birkerfeld 11
83627 Warngau
Germany

We look forward to reaching new heights with you as part of the team. Hope to see you soon!

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