- Support the preparation of regulatory documentation and submission activities to meet business and agency milestones.
- Lead the development and submission of initial INDs.
- Create submission plans and manage timelines in MS Project, and document workflow from draft through finalization for US submissions.
- Prepares routine submissions in compliance with department and regulatory requirements and guidelines. Assists with larger or more complex submissions.
- Identify risks to timeline and assists the North American (NA) Regulatory lead
- Work with Regulatory Operations to identify resource requirements and strategies to address overlapping resource demands and rate limiting factors
- Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed
- Ensure regulatory plans are monitored, progress/variance communicated on assigned programs
- Collaborate within regulatory and cross-functional colleagues on the preparation and submission of regulatory filings, including major marketing applications in the US.
- Prepare and review sections of regulatory submissions for IND/CTA original submissions and amendments, orphan designations, and pediatric investigation plans
- Participate in regulatory research activities, as needed.
Skills:
- Minimum 4-6 years of regulatory experience in a biotech/pharma company
- Excellent project management and writing skills, as well as a good understanding of the underlying science
- Experience with preparation of initial INDs, DSURs and meeting briefing documents. Experience with BLA, NDA, or MAA a plus.
- Understanding of the development of drugs and/or innovative biologics products. Experience in orphan drugs a plus
- a working understanding of regulations and guidelines related to drug development and registration is required.
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
- Independently motivated, detail oriented and good problem-solving ability
- Demonstrated ability to handle multiple projects is required.
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
- Excellent communication skills and ability to influence across multiple functions
Education:
BS in pharmaceutical-related scientific field