Regulatory Affairs Manager AT-CEE-RU-CIS (m/f) (Ref. No.: AT-00707)

Mercuri Urval GmbH

Place of work
Austria
Contract type
full-time
Start date
01.01.2017

Information about the position

Job description, responsibilities and duties

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

Company on whose behalf the position is being filled

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.

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)
University education (Master's degree)

Educational Specialization

pharmacy, chemistry, biology, medicine

Language skills

English - Advanced (C1) and
German - Intermediate (B1)

Personality requirements and skills

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

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

Advertiser

Brief description of the company

Since its foundation in Sweden in 1967, Mercuri Urval has developed to become one of the leading Management Consulting Firms. Today we assist more than 10,000 active client organisations per year in more than 22 countries throughout Europe, North and South America, Australia and Singapore. Mercuri Urval is a privately owned, independent company that works as one organisation, applying the same standards, concepts and code of conduct to local and individual needs, which has provided us with constant organic growth. This development is acknowledged by our clients and serves as the decisive point of departure when advising them on business potential and opportunities. All methods and tools supporting our activities are developed internally at the Mercuri Urval International Research Institute.

Today, more than 800 dedicated Mercuri Urval employees are supporting the business development activities at our client organisations and assist managers, key employees and candidates in a professional and effective way. Consecutive programs on education, training and development involve all Mercuri Urval employees and take place at Mercuri Urval’s international and local offices. Representing very different backgrounds our employees share their experiences, motivation and - most important - their insight, which contributes to the corporate performance in our client organisations.

Company address

Mercuri Urval GmbH
Handelskai 92, Rivergate
1200 Vienna
Austria
http://www.mercuriurval.at

Contact

Contact person: Doris Hofmeister
Tel.: +4315065517
E-mail: send CV
Send CV to the company
ID: 2816629   Dátum zverejnenia: 17.11.2016