Associate Manager / Manager Regulatory Affairs
The Associate Manager/ Manager Regulatory Affairs will be responsible for assisting in the strategic and administrative regulatory aspects of oncology drug product development (pre-submission through post-approval). This position reports to the Senior Director of Regulatory Affairs.
- Individual contributor supporting the regulatory deliverables, as part of the larger organizational goals.
- Under direction, represents the department on assigned projects (e.g. study teams).
- Assist RA management in providing guidance and addressing issues. May work with varying degrees of independence on select projects.
- Responsible for assisting in the preparation, including writing, of the R&D portions of regulatory submissions.
- Maintain awareness of changes in regulatory requirements for effective submissions.
- Ensure that quality, accuracy, and format of electronic and paper formatted submissions comply with applicable laws and regulations.
- Identify potential problems and provide guidance to document authors or team members as appropriate.
- Assist manager with regulatory strategy formulation through research, analysis, and evaluation of alternative approaches.
- Assist in the coordination of regulatory agency meetings and preparation of meeting materials.
- Cross-functional collaboration.
- Demonstrate understanding of regulations and guidelines governing drug development (particularly clinical drug development) including the ability to apply these to overall strategic drug development.
- Minimum of a bachelor’s degree or equivalent experience.
- Master’s degree, PharmD, Ph.D. or other higher education would be a plus.
- 5 years of regulatory affairs experience or equivalent education and training.
- Good background in general biological/physical science and the ability to apply that knowledge to moderately complex R&D regulatory issues.
- Prior regulatory submissions experience in US pharmaceutical product development. Experience with all types of submissions, including INDs, NDAs, and post-approval supplements.
- Understanding and experience in all aspects of Regulatory (Development, CMC and Operations)
- Demonstrated understanding of regulations and guidelines governing drug development (particularly clinical drug development) including the ability to apply these to overall strategic drug development.
- Ability to review and interpret regulations as they apply to products.
- Experience with FDA interactions would be a plus.
- Oncology drug development experience a plus.
- Ability to work with minimal supervision
- Able to address issues in functional areas
- Ability to identify compliance risks and escalate when necessary
- Ability to identify and recommend solutions to problems
- Energetic, resourceful self-starter with high integrity
- Intellectually curious, enthusiastic, creative
- Excellent communication skills
- Team-player comfortable in fast-moving, dynamic environments.
Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to eradicate cancer globally. The company’s existing pipeline consists of five development-stage assets including two-novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and three targeted therapies against uncontrolled growth signaling pathways.