Global Regulatory Strategist, Cell and Gene Therapy

Global Regulatory Strategist, Cell and Gene Therapy

Sanofi

Amsterdam, Netherlands

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

About the Job

As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU and/or global regulatory strategy for assigned projects, including Health Authority (HA) interactions. The RS provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Duties & Responsibilities

• Enables the GRL by providing quality regulatory input and position to internal business partners, including but not limited to the clinical development teams, commercial and GRT for assigned projects;
• Contributes to the GRT for assigned projects in alignment with the team’s one regulatory voice for providing strategic input on the Target Product Profile (TPP), business planning, governance, and committees. May be requested to lead GRT meetings;
• Contributes to the development of the Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for life cycle management of products;
• May serve as a regional/local regulatory lead and point of contact with HAs for projects/products in their remit, as needed;
• Accountable for developing the HA engagement and interaction plans for their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading the team through meeting preparations and moderating the meeting itself for the projects in their remit;
• May lead HA meetings and preparations as designated;
• Leads submission team or regulatory sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for the development and update of the core global dossier / collaborates with regional lead where region-specific submissions are applicable;
• Leads the IND/ CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation;
• Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, and document management utilizing the support and input of cross functional team and/or alliance partners where relevant.

About you

• BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred;
• At least 6 years of prior pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in development phase;
• Experience with clinical development of drugs and/or innovative biologics products. Gene and cell therapies preferred;
• Demonstrated experience with preparation of (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing documents and negotiating with a national/regional Health Authority preferred;
• Experience on multidisciplinary matrixed project teams (e.g. clinical study team) preferred;
• Project leadership experience preferred.

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