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

CSL Plasma•Holly Springs, NC

About The Position

The Senior Manager, Regional Regulatory Lead (RRL), North America Seqirus Vaccines in the Global Regulatory Strategy (GRS) team is a member of the GRA GRS Vaccines Therapeutic Area (TA) and contributes to the vision and goals of CSL. This role serves as a regulatory leader who leverages North America regulatory experience and expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision and strategies for assigned products with a patient-centric focus. The RRL will leverage regional commercial insights and apply prudent risk-taking to ensure timely delivery of successful regulatory outcomes. This role effectively partners with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) members to ensure appropriate inputs into risk assessment and decision making. It ensures bi-directional communication with stationed region commercial operations and GRA. The RRL will engage with local health authorities (FDA and Health Canada), maintain productive relationships with HA contacts, and drive positive regulatory outcomes for assigned products in conjunction with the Global Regulatory Lead (GRL). This role offers an aspirational and future development opportunity to lead product health authority interactions with support. The RRL will partner with GRAST members to achieve regulatory deliverables, including leading assigned tasks, while fostering individual accountability, team spirit, and actively contributing to and executing decisions expeditiously, resulting in positive regulatory outcomes.

Requirements

Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science required.
Minimum of 7 years’ experience in the biotech or pharmaceutical industry.
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 the 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.

Nice To Haves

Advanced degree (MS, PhD, MD, DVM) or MBA preferred.

Responsibilities

Accountable for assigned product relationship with a health authority (FDA and Health Canada), ensuring alignment with product GRL and Head, Regulatory TA.
Aspirational and development potential to lead assigned negotiations, with support, on behalf of CSL with health authority to achieve desired regulatory outcomes.
Regional expert regarding health authority requirements, regulatory filing pathway/categories, processes and ways of working, providing relevant guidance/assessment to internal stakeholders on addressing project challenges, leveraging regulatory opportunities, and advising on risk for developmental, new, and marketed products.
Under the product GRL, contributes to regional regulatory activities as assigned, inclusive of potential to lead/support core document preparation (e.g., core briefing book, pediatric plans, etc.), product filing preparation activities (investigational, new, and marketed), and health authority engagements.
Responsible for Module 1 documentation required for submission and supports response to health authority comments activities with guidance from GRL.
Actively contribute to GRAST activities, strategy development, document reviews, and competitive regulatory intelligence.
Ensures on-time execution of regulatory activities at the regional level, achieving positive regulatory outcomes.
Partners with GRL to develop internal communications and distributes GRAS communications to regional commercial stakeholders.
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.