This role is an opportunity for a motivated, highly collaborative, and organized individual to impact the long-term value of Idera’s portfolio through efficient delivery of strategically-guided regulatory submissions. This role will also work closely with the cross-functional study/project team in contributing to the development of regulatory and overall product development strategies.
· Contribute to development of regulatory strategies for assigned projects that align with overall product strategy and will result in the on-time submission and approval of new products, indications, and variations.
· Ensure that agreed strategy is appropriately reflected in IND, NDA, sNDA, and other required US and ex-US regulatory filings (e.g., CTA, MAA) and activities.
· Develop and maintain highly collaborative working relationships with relevant regulatory authorities.
· Ensure compliant and quality implementation of regulatory activities in accordance with agreed strategy and with compliance requirements.
· Plan and coordinate all aspects of regulatory submissions necessary to support global clinical trials and product registrations.
· Ensure high quality and timely regulatory submissions and interactions.
· Maintain current knowledge of FDA regulations and guidance regarding INDs, NDAs and electronic submission requirements, as well as familiarity with analogous EMA regulations and guidance.
· Identify and implement opportunities to improve internal regulatory operations processes.
Education & Experience Requirements
Other Job Requirements