Associate Director of Clinical Compliance responsible for ensuring compliance with health authority regulations. Overseeing clinical development quality and guiding cross - functional initiatives.
About the role
- Senior Manager Regional Regulatory Lead at CSL Behring developing global regulatory strategies for vaccines. Leading interactions with FDA and EMA and ensuring timely regulatory outcomes.
Responsibilities
- Regulatory leaders who support development of a global, integrated regulatory strategy ensuring innovative, scientifically sound regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging appropriate business insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes.
- Key member, partner and single GRA representative for the respective Product Strategy Teams (PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, ‘One GRA Voice’ and engagement with internal GRAS partners.
- Supporting, potentially leading, health authority interactions in stationed country (FDA or EMA) and maintaining productive relationship and driving positive regulatory outcomes with both FDA & EMA plus global health authorities.
- Engaging GRAST members to achieve regulatory deliverables (including assign tasks) while fostering individual accountability, ‘team spirit’, and act as regulatory decision maker/approver for GRAST / GRA related project deliverables as needed.
- Within GRAST, effectively foster two-communication between GRAST and R&D teams ( e.g. PST), encourage robust regulatory scenario assessment and accountable for delivery of successful regulatory outcomes globally.
Requirements
- 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.
- 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.
- Experience in working in teams with either a direct or matrix manager.
- Candidates have developing knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in one key region (EU, US, Japan).
- Experience working in Regulatory Affairs with agency interaction responsibility with at least 1 health authority.
- Relevant experience working in a complex and matrix environment is preferred.
- Ideal candidates will have a relevant clinical or device foundation.
Benefits
- CSL employees that work at least 30 hours per week are eligible for benefits effective day 1.
- We are committed to the wellbeing of our employees and their loved ones.
- CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters.
- Our benefits are designed to support the needs of our employees at every stage of their life.
- Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
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