Associate Manager Regulatory Affairs (d/f/m)

Job title:

Associate Manager Regulatory Affairs (d/f/m)

Company

Novartis

Job description

Job Description Summary Associate Manager Regulatory Affairs (d/f/m) | Kundl, Tyrol, AustriaJob DescriptionSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future is ours to shape!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

What you’ll bring to the role:Essential Requirements:

• University degree in natural sciences, ideally PhD, alternatively several years of regulatory or other relevant industry experience or comparable qualification
• First work experience in pharmaceutical or biotech regulatory affairs desirable
• Good interpersonal and communication skills
• Ability to work effectively in a matrix environment in a multi-cultural setting
• Proficient in English (oral and written)

Desirable requirements

• Strong communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams
• Ability to interpret scientific data and to construct persuasive regulatory documents

Your benefits:Attractive salary with incentive programModern company pension schemeFlexible working hours / home-office depending on the position14 weeks of paid parental leaveAdditional days off (bridge-days) for more leisure timeSubsidized meals in our canteenSustainable mobility in the form of company transportation, shift buses and car sharingCompany day-care and summer camps for childrenWellbeing & mental health offersLearning and development options for your personal and professional growthWorldwide career opportunitiesIn 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 EUR 58.199,96/year (on a full-time basis).We also offer a potential market-oriented excess payment in line with your experience and qualifications.Why Sandoz?Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provides more than 800 million patient treatments to over 700 million patients every year and while we are proud of this achievement, we have an ambition to do more!With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.Our momentum and entrepreneurial spirit are powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!Commitment to Diversity & Inclusion:We are committed to building an outstanding, inclusive work environment and fostering diverse teams, that represent the patients and communities we serve.Are you ready to join us? Then we look forward to your application!Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here:#SandozSkills Desired Cross-Functional Teamwork, Government Affairs, Pharmaceutical Industry, Regulatory Compliance

Expected salary

€58199.96 per year

Location

Kundl, Tirol

Job date

Sat, 08 Mar 2025 01:11:30 GMT

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