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

About the role

The Senior Manager, Regional Regulatory Lead - North America for Seqirus Vaccines plays a critical role within the Global Regulatory Affairs & Safety (GRAS) organization. This role can be located at CSL Seqirus US offices in Holly Springs, NC, Summit, NJ, or Waltham, MA, or in Quebec, Canada. It is a hybrid position requiring onsite work three days a week. Reporting to the Director, Global Regulatory Lead, this role contributes to CSL's vision and goals by:

• Acting as a regulatory leader who leverages North America regulatory experience/expertise to contribute to an innovative, scientifically sound, global, integrated regulatory vision/stategies for assigned products with a patient-centric focus.
• Effectively partnering with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) members to ensure appropriate inputs into risk assessment and decision-making.
• Engaging with local health authorities (HA), FDA, and Health Canada, maintaining productive relationships with HA contacts and driving positive regulatory outcomes for assigned products in conjunction with the Global Regulatory Lead (GRL).
• Partnering with GRAST members to achieve regulatory deliverables (including leading assigned tasks) while fostering individual accountability, 'team spirit', and actively contributing to decisions expeditiously, resulting in positive regulatory outcomes.

Responsibilities

• Accountable for assigned product relationships with health authorities (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 authorities to achieve desired regulatory outcomes.
• Regional expert regarding health authority requirements, regulatory filing pathways/processes, and ways of working, providing relevant guidance/advice to internal stakeholders on addressing project challenges, leveraging regulatory opportunities, and advising on risks for developmental, new, and marketed products.
• Contributing to regional regulatory activities as assigned, including 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 supporting response to health authority comments activities with guidance from GRL.
• Actively contributing 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 distribute GRAS communications to regional commercial stakeholders.
• Actively connecting and maintaining relationships with GRAST members, including GRAS Regions and Regulatory CMC.
• Proactively fostering and promoting effective relationships across Global Regulatory Strategy. Updates and maintains applicable regulatory systems to ensure tracking and compliance of deliverables.
• Applies CSL leadership capabilities.

Qualifications

• 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.
• Experience: At least 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.

Pay

The expected base salary range for this position at hiring is $154,000 to $182,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the Summit, NJ & Waltham, MA locations as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies, and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation.

Benefits

To learn more about CSL benefits, visit .

About CSL Seqirus

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. For more information on CSL, CSL Behring, CSL Seqirus, and CSL Vifor, visit . To learn more about inclusion and belonging at CSL, visit .

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit .

Contact Information

To learn more about CSL Seqirus, watch our 'On the Front Line' video at .

Areas of Expertise

• Rare and Serious Diseases
• Influenza Vaccines
• Iron Deficiency and Nephrology