Regulatory Affairs Manager (m/f/d)

Regulatory Affairs Manager (m/f/d)

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.

• 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.

• 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.

• 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

If you can imagine this position as the next step in your career, then apply online via our applicant portal so that we can treat your data confidentially and in compliance with the GDPR.

Our HR recruiting team will get in touch with you immediately.´
We are filling this position by ourselves - please no inquiries from headhunters and recruiters.

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