Jul 18, 2022

Job Description

Associate Manager Regulatory Digital Solutions and Regulatory Labelling (f/m/d), Schaftenau, Tyrol, Austria

8! This is the number of biosimilars for which Sandoz has already received a marketing authorization, and that already provided increased access to life-saving medicines to patients worldwide while further biosimilars are under development.

As an Associate Manager Regulatory Digital Solutions and Regulatory Labeling you will get both an overarching view and drive improvement and efficiency of IT systems and business processes used in Regulatory Affairs Sandoz Biopharma, as well as take over responsibility in providing strategic regulatory input and operational support from Regulatory Labeling perspective for our biosimilars during all relevant development phases.

You will be responsible for project management, strategic and operational support in regulatory IT system, digital, and process related activities as well as managing the compilation and review of Regulatory Labeling-related documentation and dossier sections. You are interested in starting or continuing a journey within Biopharma Regulatory interface that will give you an overarching view at the interface between Regulatory Affairs, Regulatory IT systems and related business processes, as well as gaining broad regulatory knowledge relevant for biosimilars starting with the Regulatory Labeling field while bringing along a collaborative and patient-focused mind-set.

Your key responsibilities:

Your responsibilities include, but are not limited to:
• Project management / lead or support of projects/activities in the transformation process, implementation and replacement of regulatory systems, especially regulatory information, document and submission management systems and data migration and coordinate, lead or support routine regulatory systems related activities and digital solutions to improve processes and to facilitate operational tasks
• Representation in project teams and project management / lead or support of all Regulatory Labeling related activities such as preparation of Patient Information Leaflets (PIL), Labeling and Summary of Product Characteristics (SmPC) according to valid internal policies and guidelines, and coordination of EU PIL readability tests (user tests) for all new biosimilar applications
• Evaluate regulatory requirements and provide regulatory strategies when preparing or managing the timely delivery of high quality documentation required for clinical trials, initial marketing authorization applications and dossier reviews worldwide
• Identify potential regulatory gaps besides providing risk mitigation and minimization measures during strategic evaluations
• Provide input and collaborate with partners about implementing strategies, ensuring timelines and requirements, or assuring congruency and compliance
• As an active member of the regulatory project (sub) team may act as representative of regulatory functions in the global project team(s)
• Own the preparation of responses to regulatory relevant queries from various partners and directly interact with regulatory authorities and/or with regulatory functions in the countries

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• University degree in Natural Sciences, ideally PhD, alternatively initial experience in Regulatory Affairs or other relevant industry experience or comparable qualification
• Proficient in English (both oral and written)
• Interest in IT systems
• Strong interest and motivation in gaining diverse experience in several fields of Regulatory Affairs
• Good interpersonal and communication skills as well as the ability to work well in interdisciplinary teams
• Ability to work effectively in a matrix environment in a multi-cultural setting

Desirable requirements:
• Ability to interpret scientific data and to construct persuasive regulatory documents

Why Novartis?

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 €49,804.58 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
BioPharma SZ
Research & Development
Full Time
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Associate Manager Regulatory Affairs (f/m/d)

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