Regulatory Affairs Specialist (f/m/d), Vienna, Austria
10! highly motivated associates are working within Regulatory Affairs Novartis Pharma ensuring that innovative medicines are delivered to patients. As Regulatory Affairs Specialist (m/f/d) you will closely work with internal and external stakeholders and will be responsible for the compilation and submission of variations and for the end-to-end artwork labeling process.
Your key responsibilities:
• Manage medium to small level global regulatory submission projects
• Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products
• Contribute to strategic and technical input/support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products
• Write, edit and/or manage the production of high-quality clinical documentation for submission to regulatory authorities in support of marketing applications
• Develop professional expertise, applies company policies & procedures to resolve a variety of issues
• Represent organization on specific projects
• Work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Refer to established policies & procedures for guidance
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you’ll bring to the role:
• Completed secondary or higher education (HAK/FH)
• Previous work experience in a similar role
• Structural working style
• Team player
• Ability to work under pressure
• Open communication style
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is ₠ 49.804,58/year (on a full-time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network