Regulatory Affairs Labeling (Senior) Associate (f/m/d), Schaftenau, Tyrol, Austria
8! That is the number of biosimilars for which Sandoz has already received marketing authorization, and that has provided increased access to life-saving medicines to patients worldwide while further biosimilars are under development. As a Regulatory Affairs Labeling Associate (f/m/d) you will contribute to bringing new biosimilars to market as well as to keeping the marketing authorization for already approved products. You will be responsible for providing operational support for the compilation of biosimilar labeling dossiers including patient leaflets. You are interested in continuing a journey within Biopharmaceutical Regulatory Affairs that will enable you to gain the regulatory knowledge relevant for biosimilars while bringing along a collaborative and patient-focused mindset.
Your key responsibilities:
Your responsibilities include, but are not limited to:
•Support all aspects related to the planning, coordination, preparation of high quality labeling documentation (CTD documents)
•Support preparation of high quality labeling documentation (CTD documents) in non-EU countries and during implementation of prompt and complete responses to regulatory labeling relevant queries from various stakeholders (e.g. Health Authorities, COs).
•Collaborate closely and support mutually within team, department, as well as with DRA colleagues in country organizations (COs) and with Sandoz agents where no CO exists with regard to labeling related topics and with applicable collaboration partners
•Support implementation of prompt and complete responses to regulatory labeling relevant queries from various stakeholders (e.g. Health Authorities, COs).
•Support defining and implementing regulatory strategy for above-mentioned activities through participation in Global Program Regulatory Sub-Teams.
•Contribute in activities to define or update regulatory compliance activities (e.g. entering product-specific attributes as provided by program team representative into databases. Participates in Labeling related strategic initiatives and business process improvements to further enhance core business processes resulting in cycle time reduction and enhanced compliance.
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:
• Proactive and independent handling of own and overarching tasks to work effectively in a matrix environment within a multi-cultural setting
• Knowledge of regulatory business processes and related tools
• Proficient in English (both oral and written)
• Good interpersonal negotiation and communication skills
• Ability to work independently under pressure while demonstrating initiative and flexibility in lateral support and development across groups within regulatory
• Ability to plan and prioritize workload
• Attention to detail and quality focused
• Ability to work in interdisciplinary teams
• University degree
• Previous experience in biosimilar regulatory labeling
766 million lives were touched by Novartis medicines in 2021, 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 €39,625.32 per 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