Regulatory Affairs Manager (m/f/d), GDD Regulatory Affairs, Vienna, Austria
212! This is the number of marketed products for which we currently handle all regulatory matters. As Regulatory Affairs Manager, you will be responsible for the whole range of regulatory tasks concerning the product portfolio and ensure compliance with drug law and pharmaceutical guidelines and regulations. Apply now to become a part of our dynamic team!
Your responsibilities include, but are not limited to:
• Perform all submission and approvals according to the timetable given by the headquarter or according to the priority ranking of the local marketing
• Adapt regulatory documents according to local legal requirements
• Prepare all labelling documents and track timely submission at the authorities
• Act as point of contact for regulatory authorities and provide regulatory input to reimbursement applications
• Check promotional material for regulatory conformity
• Prepare and attend regulatory audits and work in close cooperation with other departments such as Marketing, Market Access and Reimbursement
• Provide strategic regulatory know-how during launch and reimbursement processes while transferring timely and accurate entries into relevant databases
What you'll bring to the role:
• University degree in life sciences, pharmacy, medicine or comparable education
• 3-5 years of experience in Regulatory Affairs or a related field
• Ability to deal with tight timelines whilst delivering high quality and ensuring compliance with SOPs
• Open-minded, flexible, and solution oriented personality with a high quality and customer focus
• Strong and efficient communications, interpersonal, and negotiation skills
• Team player with an international mindset
• Highly organized expert who offers a great capability of workflow prioritization and who is driven by a structured and accurate way of working
• Excellent verbal and written skills in German and English are mandatory
• Experience in the usage of regulatory affairs databases is preferred
• Proven and practical knowledge of national and EU legal requirements beneficial
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least EUR 24,164.00EUR per year on a full time basis).
Imagine what you could do at Novartis!
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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