Manager, Regional Regulatory Lead – LCM

• Regulatory leaders who leverage regional regulatory experience to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus.
• Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) and other regional, labeling and CMC GRAST members.
• Ensure bi-directional communication with stationed region commercial operations and GRA.
• Engage with health authority (HA) in stationed country (FDA or EMA).
• Contribute to product health authority interaction with support GRL or Regulatory TA Head.
• Partner with GRAST members to achieve regulatory deliverables.
• Update and maintain applicable regulatory systems (e.g., Veeva) to ensure tracking and compliance deliverables.

• Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or related life science field.
• Advanced degree in a related field (MS, PhD, or MD, DVM) or MBA is preferred
• Minimum of 5+ years of regulatory/submission experience in the biotech or pharmaceutical industry
• 3+ years of experience working on developmental products
• Knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in one or more key regions (EU, US, Japan)
• Experience working in Regulatory Affairs with agency interaction responsibility with at least one health authority is preferred.
• Relevant experience working in a complex and matrix environment.
• Ideal candidates will have clinical or device foundation
• Demonstrated ability to think strategically, assesses prudent risks and develop bold, agile, innovative approaches to complex challenges
• Proven effective verbal and written communication skills and ability to successfully work across all levels of the organization
• Foster productive, working relationships within CSL (e.g., R&D and Commercial).

Demonstrates extensive regulatory experience in the biotech or pharmaceutical industry, with a strong focus on product development and approval processes in key regions such as the EU and US. Proven ability to engage with health authorities and maintain compliance through effective communication and collaboration within a complex, matrix environment.

• Regulatory Affairs Experience
• Health Authority Interaction
• Pharmaceutical Product Development
• Strategic Thinking
• Communication Skills

• Regulatory Strategy
• Global Regulatory Affairs
• FDA
• EMA
• Complex Environment
• Matrix Environment
• Developmental Products
• Patient-Centric Focus
• Regulatory Deliverables
• Commercial Operations