Senior Manager, Regional Regulatory Lead – North America

CSL

Senior Manager, Regional Regulatory Lead managing regulatory strategies for North American Seqirus Vaccines. Engaging with health authorities to achieve regulatory approvals and compliance in the market.

Posted 4/23/2026full-timeHolly Springs • Massachusetts, New Jersey • 🇺🇸 United StatesSenior💰 $154,000 - $182,000 per yearWebsite

About the role

Key responsibilities & impact

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 and thus, can provide relevant guidance / assessment to internal stakeholders on means to address project challenges, leverage regulatory opportunities and advise 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 the 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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory filingcore document preparationModule 1 documentationregulatory intelligenceregulatory compliancehealth authority engagementproduct filing preparationrisk assessmentproject managementdata analysis

Soft Skills

leadershipcommunicationrelationship managementstrategic thinkingcollaborationproblem-solvingnegotiationorganizational skillsadaptabilityproactive engagement

Certifications

Bachelor’s degreeMSPhDMDDVMMBA