Apr 26, 2022

Job Description

Regulatory CMC Director (f/m/d) - Biosimilars, Global Drug Development, Schaftenau, Austria

583! That is the total number of projects and products on our Global Regulatory Affairs CMC project list. All of these innovative projects are aimed at making a difference in patients’ lives and we need your support.

As a senior member of our Global Regulatory Affairs CMC team, your role would be to establish and drive global CMC regulatory strategic and operational direction and documentation for complex biosimilar projects and products covering development, registration and approval/post approval activities.

Your key responsibilities:

Your responsibilities include, but are not limited to:
• Formulate, lead and drive global CMC regulatory strategy for biosimilar projects/products drawing on extensive regulatory expertise with a focus on innovation, maximizing the business benefit balanced with regulatory risks and compliance
• Lead and drive all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions
• Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
• Author and/or review high-quality CMC documentation for Health Authority submissions, establishing and applying CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements
• Represent Global Regulatory CMC on cross-functional project teams and maintain collaborative partnerships with stakeholders
• Initiate and lead Health Authority interactions and negotiations including more complex interactions: setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans
• Act as a role model, providing strategic advice within and outside of RA CMC, driving continuous improvement and building the talent within the team through coaching and mentoring

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:
• Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading, planning and prioritizing activities simultaneously on multiple projects
• Demonstrated ability for innovative and big picture thinking
• Strong planning, negotiation, organizational and interpersonal skills
• Excellent written/spoken communication and negotiation skills

Desirable requirements:
• Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent; advanced degree desired
• Minimum 10 years of regulatory CMC experience and/or pharmaceutical industry experience
• Extensive knowledge/experience in regulatory submission and approval processes and ability to solve complex CMC regulatory issues and requirements
• Proven ability to critically evaluate data from a broad range of scientific disciplines

Why Novartis?
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 € 69.735,96/year (on a full time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

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
Global Drug Development
Research & Development
Full Time
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Regulatory CMC Director (f/m/d) - Biosimilars

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