About this role
Role Overview
- Accountable for assigned product relationship with a health authority (FDA or EMA), ensuring alignment with product GRL and as needed, support from Head, Regulatory TA if escalation is required.
- Actively negotiates on behalf of CSL with health authority to achieve desired regional expert regarding health authority requirements, regulatory filing pathway/categories, processes and ways of working and thus, can provide sound guidance/assessment to internal stakeholders (e.g. GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new and marketed products.
- Under the product GRL, leads regional regulatory activities as assigned, inclusive of potential to lead 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 leads 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.
Requirements
- A bachelor’s degree (four-year university degree) in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is required.
- An advanced degree in a related field (MS, PhD or MD, DVM) or MBA is preferred.
- 10+ years’ experience in the biotech or pharmaceutical industry, with at least 5 years of regulatory experience, including 3 years working on developmental products.
- Experience in leading teams (preferred 3 years) as a direct or matrix manager, setting direction, holding people accountable and fostering a collaborative, empowered, team environment.
- Candidates have knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one key region (EU, US, Japan).
- Experience working in Regulatory Affairs with direct agency interaction responsibility with at least 1 health authority.
Benefits
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
- You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are.
- Celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.