Regulatory Affairs Manager (m/f/d)

Croma-Pharma GmbH; Gemeinde Leobendorf; Hybrid; EUR 55.000 - 67.000; Vollzeit

Benefits dieser Stelle

Flexible working hours and home office

Good public transport connections and

Croma restaurant with meal allowance

Pension and health care

Professional development

Zusammenfassung

CROMA-PHARMA is an internationally active pharmaceutical company with headquarters in Leobendorf, Austria. We seek a Regulatory Affairs Manager to oversee global regulatory projects for aesthetic medical devices, plan registrations, and maintain registrations across regions.

Based in Leobendorf with hybrid work, you bring 3–5 years of regulatory experience in the medical industry, a Life Sciences degree, and a proven dossier submission track record.

Qualifikationen

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field (Master’s preferred).
• 3–5 years of regulatory affairs experience in the medical industry, ideally with high risk and substance based devices.
• Proven track record of preparing and submitting regulatory dossiers and managing projects on a global scale.
• Russian language as a plus.

Aufgaben

• Manage regulatory projects for aesthetic medical devices on a global scale in ASEAN countries and Russia.
• Plan and implement medical devices registrations in these areas and insure maintenance of registrations.
• Assess change notifications and prepare/submit variations to registrations and insure their timely renewal.
• Oversee regulatory requirements in countries and insure compliance within the quality management system.
• Communicate with external stakeholders such as regulatory consultants and Distributors.
• Conduct regulatory intelligence, internal trainings and maintain overviews.

Kenntnisse

Regulatory affairs

Project management

Dossier submission

Russian language

Ausbildung

Bachelor's degree in Life Sciences / related field

Jobbeschreibung

Regulatory Affairs Manager (m/f/d)

Leobendorf / Hybrid

from € 60.977,70 per year

38 hours per week

CROMA-PHARMA is an internationally active pharmaceutical company with its headquarter in Leobendorf, Korneuburg district, in the north of Vienna. Many years of experience in the manufacturing of products based on hyaluronic acid and a unique level of expertise in the field of aesthetic medicine have made CROMA-PHARMA a globally renowned specialist in the dynamic and versatile business of anti‑aging.

At Croma-Pharma, we are committed to developing and marketing innovative products that help our customers improve their well‑being. Join us and grow with us.

Your task

• Manage regulatory projects for aesthetic medical devices on a global scale in ASEAN countries and Russia.
• Plan and implement medical devices registrations in these areas and insure maintenance of registrations.
• Assess change notifications and prepare/submit variations to registrations and insure their timely renewal.
• Oversee regulatory requirements in countries and insure compliance within the quality management system.
• Communicate with external stakeholders such as regulatory consultants and Distributors.
• Conduct regulatory intelligence, internal trainings and maintain overviews.

Your profile

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field (Master’s preferred).
• 3–5 years of regulatory affairs experience in the medical industry, ideally with high risk and substance based devices.
• Proven track record of preparing and submitting regulatory dossiers and managing projects on a global scale.
• Russian language as a plus.

Want to find out more about us?

Visit our website CROMA-PHARMA and follow us daily on LinkedIn.

We look forward to receiving your application.

We’re here to help with any questions you may have about applying to CROMA PHARMA.

Collective agreement for the chemical industry, 38 hours a week - the minimum gross salary according to the KV is EUR 60.977,70 for this position. The actual salary depends on the specific qualification and experience.

• Flexible working hours and home office
• Good public transport connections and free parking spaces
• Croma restaurant with meal allowance and in-house fitness center
• Pension and health care (company doctor and employee assistance programs)
• Professional development