Registration Manager

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Is responsible for implementing regulatory strategy and managing operational activities for assigned medium regions.

• Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.

• Partners with regions to align on regulatory strategy in order to fulfil business objectives -Implements RFP across assigned regions.

• Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL.

• Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.

• Develops and implements plans for timely response to HA requests and coordinates responses.

• May serve as local HA liaison depending on location (e.g., FDA or EMA).

• Drives coordination, planning, and submission of dossiers in assigned regions worldwide.

• Review of global dossier summary documents.

• Develops and implements plans to avoid/minimize clock stops during submission review.

• Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).

• Reviews and submits Risk Management Plans.

• May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL.

• Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL.

• Erroneous decisions result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activity -Contributes to and often leads the development of departmental goals and objectives.

• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

What you’ll bring to the role:

Essential Requirements:

• Functional Breadth.
• Cross Cultural Experience.
• Operations Management and Execution.
• Project Management.
• Clinical Trials.
• Detail Oriented.
• Drug Development.
• Lifesciences.
• Negotiation Skills.
• Regulatory Compliance.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last 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 is 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!

The future is ours to shape!

Commitment to Diversity & Inclusion:

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

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 Talentpool (novartis.com)

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