Regulatory CMC Manager Biosimilars (m/f/d)

328632BR
Sep 28, 2021
Austria

Job Description

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

582! 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 member of our Global Regulatory Affairs CMC team, your role would be to provide global CMC regulatory strategic and operational direction and documentation for biosimilar projects and products covering development, registration and approval/post approval activities.

Your responsibilities include, but are not limited to:
• Formulate and lead global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for biosimilar products.
• Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
• Identify the required documentation and any content, quality and/or timelines 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 HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
• Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams.
• Prepare and communicate CMC risk management assessments and lessons learned on major submissions.
• Initiate and lead Health Authority interactions and negotiations.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Global Drug Development
REG AFFAIRS GDD
Austria
Schaftenau
Research & Development
Full Time
Regular
No
328632BR

Regulatory CMC Manager Biosimilars (m/f/d)

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