Regulatory Affairs Manager (all genders) in Austria at Merck Serono SA

Vienna, Wien, Austria -

Full Time

Start Date

Immediate

Expiry Date

31 Jan, 26

Salary

55000.0

Posted On

02 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Pharmaceutical Science, Strategic Thinking, Risk Mitigation, Health Authority Interactions, Life Cycle Management, Clinical Trials, Promotional Material Review, Stakeholder Engagement, German Language, English Language, Dedication, Collaboration, Curiosity, Problem Solving

Industry

Pharmaceutical Manufacturing

Description

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Your Role: Ready to join our Austrian affiliate? We are looking for a Regulatory Affairs Manager located in Vienna. In this position you would be the main point of contact for the Austrian Health Authorities. You will perform as the local business partner to different stakeholders of the local organization. You will be responsible for key regulatory activities, including any required Health Authority interactions for the Austrian organization, to ensure maintenance of Marketing Authorizations for the company's product portfolio. Your tasks will be the life cycle management of the marketed product as well as registration of new compounds, including possible Early Access Programs for new assets and relevant support for clinical trials as applicable. Who you are: You completed a university degree in pharmaceutical science (pharmacy, chemistry, biology, or related discipline) Minimum of 4 years of experience in the regulatory affairs field (RA proficiency) Experience and knowledge in review of promotional material and artworks You understand business needs, think strategically, and develop risk mitigation strategies Excellent English and German language You are a standout colleague with a high level of dedication and a strong willingness to perform What we offer: We offer you an attractive package including benefits & flexi-time with home office opportunities. The base salary for this position starting with 55.000 € pa, taking into consideration your experience & background.

Responsibilities

The Regulatory Affairs Manager will be the main point of contact for the Austrian Health Authorities and will manage key regulatory activities to maintain Marketing Authorizations. Responsibilities include life cycle management of marketed products and registration of new compounds, including support for clinical trials.