Regulatory Affairs Manager AT-CEE-RU-CIS (m/f)

Regulatory Affairs will directly report to the Head of Medical & RA/QA Manager AT & CEE based in Vienna. In this generalist role, you will be responsible to create a regulatory project strategy for the region and act operational by yourself. You review existing processes and strive for continuing effectiveness and efficiency. A small team supports you to achieve your targets.




Your main responsibilities:

Strong interface to the Mundipharma representative offices in the CEE countries and external consultants in order to manage the Regulatory Affairs processes aligned to national business priorities

Ensure alignment across regional regulatory and local functions with regards to strategy and direction for registration activities

Review of processes and assurance of life-cycle management of the registered medicinal products

Review, assuring completion and submission of applications for new registrations and variations for the region

Update of dossiers according to EU and non-EU regulations

Leading and developing a small team located in Vienna

Providing professional advice about regulations to various stakeholders

Negotiation with local authorities

Participation in national and international meetings



Your qualifications:

University degree / PhD in natural sciences (pharmacy, chemistry, biology, medicine etc.)

Minimum 3-5 years experience in the area of regulatory affairs, preferable within a multinational company

Very good knowledge of the pharma and health care markets in the region

Knowledge of EU and non-EU regulations

Fluent English, good German – any other CEE language is an additional asset

Very good IT skills

Willingness to travel within the region

Proven leadership experience

Generalist with a holistic view and hands-on mentality

Natural leader with strong ability to work in international teams

High level of integrity

Very good and efficient communicator and able to cooperate with multiple departments



Our client Mundipharma is proud to be among the best employers in different countries. Open communication and an appreciative approach shape everyday working life. The corporate culture is determined by social and entrepreneurial responsibility for employees and for the enterprise.


We offer a position with the ability to influence by setting a footprint, realising your own ideas and take decisions quickly. The salary package is attractive and amounts to EUR 63.000,- gross per year, the willingness to overpay is given depending on your experience and qualification.


If you are interested in this challenging position please click on this link to submit your motivation letter and CV.
http://www.mercuriurval.com/en/Countries/Austria/Jobs/One-Job-Ad/Apply/?ad=45024


If you have any questions please don’t hesitate to contact Doris Hofmeister by phone +43 1 50 65 5-17. We guarantee all applicants strict confidentiality.

Mercuri Urval GmbH
Handelskai 92
AT-1200 Vienna, Austria
www.mercuriurval.com

Hospitals, medical practice activities, other human health activities

Mundipharma is part of an international network of independent associated entities and is one of the leading medium-sized pharmaceutical companies in Austria. As a modern pharmaceutical service company Mundipharma is developing highly effective medicines for use in pain management, oncology, opioid dependence and respiratory diseases, thus providing to improve the quality of life of affected patients. The Vienna entity is acting as a Head Office for the Central Eastern Europe region and is offering this position based in Vienna.