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Senior Manager, Regional Regulatory Lead - North America, Seqirus Vaccines at Csl

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Senior Manager, Regional Regulatory Lead - North America, Seqirus Vaccines

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Csl · Seqirus Usa - NC - Holly Springs

$154K–$182K/yrFull-timeHybridToday

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Responsibilities

Actively connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC.
Proactively fosters and promotes effective relationships across Global Regulatory Strategy. Updates and maintains applicable regulatory systems to ensure tracking and compliance of deliverables.
Applies CSL leadership capabilities.

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Requirements

Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science required. Advanced degree (MS, PhD, MD, DVM) or MBA preferred.
Minimum of 7 years' experience in the biotech or pharmaceutical industry, with at least 5 years of regulatory experience, including 3 years working on developmental products.
Understanding of regulatory requirements for pharmaceutical/biological product development and approval in North America region.
Experience working in Regulatory Affairs, interacting directly with at least one health authority (FDA or Health Canada).
Experience working in a complex, matrix environment preferred.
About CSL Seqirus
CSL Seqirus is part of CSL. As one of the largest influenza vaccine provi

Benefits

Health insuranceVision insurance

Additional Information

CSL Seqirus is a leading global vaccine company, dedicated to advancing and protecting public health. We are seeking an experienced Senior Manager, Regional Regulatory Lead-North America for Vaccines to play a critical role within Global Regulatory Affairs & Safety (GRAS) organization. The role can be located either at our CSL Seqirus US offices of Holly Springs NC, Summit NJ or Waltham MA, or at our Quebec, Canada site. This is a hybrid position and is onsite three days a week. You will report to the Director, Global Regulatory Lead. The role contributes to the vision and goals of CSL as: Regulatory leader who leverages North America regulatory experience / expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) members to ensure appropriate inputs into risk assessment and decision making. Ensures bi-directional communication with stationed region commercial operations and GRA. Engaging with local health authority (HA), FDA and Health Canada, maintaining productive relationship with HA contacts and driving positive regulatory outcomes for assigned product/s in conjunction with Global Regulatory Lead (GRL). Aspirational and future development opportunity to lead product health authority interactions with support. Partner with GRAST members to achieve regulatory deliverables (including leading assigned tasks) while fostering individual accountability, 'team spirit', actively contribute and executing on decisions expeditiously resulting in positive regulatory outcomes.

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