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 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.
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.
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