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

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. 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 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. 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. 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. 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. 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 #J-18808-Ljbffr BioSpace, Inc.