Associate Director of Regulatory Operations
The Associate Director of Regulatory Operations, level commensurate with experience, will play a crucial role in managing all aspects of regulatory submissions and operations to ensure compliance with global health authorities. This position will report to the Head of Regulatory Affairs Operations and provide strategic direction, leadership, and hands-on management of regulatory submissions, document management, and operational processes to support the development, approval, and maintenance of our product portfolio.
Responsibilities (including but not limited to):
- Manage Regulatory Operations, providing strategic direction and guidance to ensure successful execution of regulatory and submission strategies
- Ensure timely and high-quality submissions by managing the overall submission process, including timelines, quality checks, and compliance with regulatory guidelines
- Develop and maintain submission plans and timelines for all regulatory activities, providing regular updates to senior management and stakeholders
- Maintain systems for regulatory document management, tracking, publishing, and archiving to ensure compliance with regulatory requirements and data integrity
- Drive process improvement initiatives within Regulatory to enhance efficiency, compliance, and quality
- Provide regulatory intelligence and strategic advice to cross-functional teams on new regulations, guidance documents, and standards that impact product development and lifecycle management
Qualifications:
- A minimum of 8+years of industry knowledge experience
- Proven track record of successful leadership and team development
- Demonstrated experience in managing investigational and marketing applications for biologics or drug products in major markets
- Proficiency in eCTD publishing and regulatory information management systems
- High level of accuracy and attention to detail in managing complex regulatory submissions and documents
- Comfortable working in a fast-paced, dynamic environment with the ability to manage multiple projects simultaneously
About Dragonfly
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.
Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.
