Regulatory CMC Associate Director

Sandoz

Kundl, Austria

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.

Your Key Responsibilities:

Your responsibilities include, but not limited to:

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;
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: setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans;
Provide strategic advice and direction within the department and cross-functionally through specialized assignments.

What you’ll bring to the role:

Essential Requirements:

Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent; advanced degree desired;
Minimum 8 years of regulatory CMC experience or 10 years 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;
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 in English.

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