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.

Flexitime

Canteen

In-house gym

Working from home

Car park

Healthcare

Croma products

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

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