Job Description Summary
As a member of our Global Regulatory Affairs CMC (Chemistry, Manufacturing, and Control) team, your role would be to establish and drive global CMC regulatory strategic and operational direction and documentation for biosimilar projects and products covering development, registration, and approval/post-approval activities.
Job Description
Sandoz 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:
1. Formulate, lead and drive global CMC regulatory strategy for biosimilar projects/products drawing on substantial regulatory expertise with a focus on innovation, maximizing the business benefit balanced with regulatory risks and compliance.
2. Lead and drive all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions.
3. 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.
4. 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.
5. Represent Global Regulatory CMC on cross-functional project teams and maintain collaborative partnerships with stakeholders.
6. Initiate and lead Health Authority interactions and negotiations: setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
7. Provide strategic advice and direction within the department and cross-functionally through specialized assignments.
What you’ll bring to the role:
Essential Requirements:
1. Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent; advanced degree desired.
2. Minimum 8 years of regulatory CMC experience or 10 years pharmaceutical industry experience.
3. Extensive knowledge/experience in regulatory submission and approval processes and ability to solve complex CMC regulatory issues and requirements.
4. Proven ability to critically evaluate data from a broad range of scientific disciplines.
5. Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading, planning and prioritizing activities simultaneously on multiple projects.
6. Demonstrated ability for innovative and big picture thinking.
7. Strong planning, negotiation, organizational and interpersonal skills.
8. Excellent written/spoken communication and negotiation skills in English.
Your benefits:
1. Attractive salary with incentive program.
2. Modern company pension scheme.
3. Flexible working hours/home-office depending on the position.
4. 14 weeks of paid parental leave.
5. Additional days off (bridge-days) for more leisure time.
6. Subsidized meals in our canteen.
7. Sustainable mobility in the form of company transportation, shift buses, and car sharing.
8. Company day-care and summer camps for children.
9. Wellbeing & mental health offers.
10. Learning and development options for your personal and professional growth.
11. Worldwide career opportunities.
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 EUR 77.543,90/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.
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: Sandoz Talent Pool
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Skills Desired: Change Control, Drug Development, Global Project Management, Lifesciences, Negotiation Skills, Pharmaceutical Products, Product Lifecycle Management (PLM), Regulatory Compliance, Risk Management.
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