Title: Associate Director – Regulatory Affairs
Type: Permanent Role
Notes: No Corp to Corp
· Develop and implement global regulatory strategies encompassing clinical, non-clinical and CMC disciplines to support the development of multiple early development and late development drug candidates.
· Requires leadership in the development and execution of regulatory strategy with the help of cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables and management of regulatory team.
· Lead the preparation, review, assembly and submission of regulatory documentation such as INDs, other regulatory equivalents, IMPDs, expedited program designations, orphan drug applications, annual reporting and pediatric plans.
· Represent Regulatory Affairs in multi-disciplinary teams and senior management for regulatory strategies and development of early and late stage development programs.
· Coordinate and consult with subject matter experts on the content, review and publication and assembly of regulatory documentation
· Lead the strategy and prepare for Health Authority meetings
· Serve as primary liaison with Health Authority for assigned projects
· Provide advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and applicable guidance.
· Manage and build the regulatory group and manage the work of others by providing guidance to his/her team. Manage budgets and project timelines, identify and address gaps in planning and resourcing.