The Senior Regulatory Affairs Scientistis responsible for submitting routine regulatory submissions to the FDA, EMA and other health authorities. This will include, preparing, reviewing and submitting high quality content and delivering within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions include initial IND’s, CTA’s, briefing documents, amendments, supplements, annual reports, DSURs and additional documents, as needed. This role will compile and review amendments, supplements, annual reports, etc., for FDA and other health authority submissions. The Sr Scientistwill need to interact effectively with cross functional team members in order to coordinate documentation required for submissions, ensuring that timelines are met. The role will also work with Regulatory Leads to obtain approval of regulatory submissions through interactive communication with the FDA and other Health Authorities for investigational and/or marketed drug products. This role will work with RA Lead to develop regulatory strategy on preclinical, clinical and/or CMC issues or coordinate and support the team in planning and preparation for Regulatory meetings or teleconferences.Responsibilities:
- Coordinate activities to maintain regulatory filings, including planning and preparing annual reports and DSURs, as well as Investigator updates and other clinical and non-clinical information updates to INDs, CTAs, as appropriate.
- Interact with functional groups across the organization in the development of relevant data to complete regulatory submissions.
- Define contributions for submissions, communicate to functional contributors and track delivery according to agreed timelines.
- Support the development of regulatory processes to manage developmental and post-approval compliance activities.
- Support the development of regulatory processes for submission planning and management.
- Other projects and duties may be required.
- BS in a scientific discipline or equivalent education, advanced degree preferred
- Minimum 2 years’ experience in a Regulatory Affairs pharmaceutical or related environment preferred
- Experience in rare disease, gene therapy, and/or biologics, preferred
- Working knowledge of FDA requirements pertaining to submission of regulatory documents
- Demonstrated ability to coordinate submissions independently in a time intensive situation
- Experience on post-approval BLA maintenance and/or IND experience preferred
- Excellent interpersonal communication and organizational skills
- Possesses strong critical and logical thinking
- Demonstrated strong writing and communication skills
- Strong attention to detail
- Demonstrated ability to work both independently and in a team environment
- Demonstrated ability to multi-task, manage competing priorities (i.e. working on two or more projects with overlapping timelines)
- Highly flexible, adaptable, and experienced in a fast-paced environment
- Demonstrates excellent organization skills and the ability to multi-task; detail oriented.
- Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts
- Demonstrates excellent verbal and written communication skills
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law. Nearest Major Market:
Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.