Jul 05, 2022

Job Description

Associate Manager Regulatory Affairs (f/m/d), Schaftenau, Tyrol, Austria

8! This is the number of high-quality biosimilars for which Novartis Sandoz has already received a marketing authorization, and that provided increased access to life-saving medicines for patients worldwide. Additionally, Novartis Sandoz has a rich pipeline of further biosimilars under development. As an Associate Manager Regulatory Affairs (m/f/d) you provide strategic regulatory input and support for maintaining marketing authorizations worldwide and for initial submissions of biosimilar products in designated countries You are interested in gaining regulatory knowledge while bringing along a collaborative and patient-focused mind-set.

Your key responsibilities:

Your responsibilities include, but are not limited to:
• Evaluate regulatory requirements and provide regulatory strategies when preparing or managing the timely delivery of high quality documentation required for initial marketing authorization applications and dossier updates 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 cross-functional project teams and workstreams
• 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, or comparable qualification
• First work experience in pharmaceutical or biotech regulatory affairs
• Proficient in English (both spoken and written)
• Strong communication, negotiation and interpersonal skills
• Ability to work in interdisciplinary teams within a matrix environment

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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