Regulatory Affairs Leader
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.
The Regulatory Affairs Leader will lead the preparation of submissions, which may include INDs/CTAs, Briefing Documents, Orphan Drug Applications, Pediatric Plans, Marketing Applications, etc. Implicit is the ability to work with cross-functional teams to define contributions to submissions and lead submission teams for projects assigned. He or she will develop, coordinate and implement regulatory, research and administrative processes essential to successful management of gene therapy clinical trials and other supporting non-IND efforts. The lead will recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance and keep abreast of regulatory procedures and changes. A person in this position will have direct interaction with regulatory agencies on defined matters. He or she will recommend strategies for earliest possible approvals of clinical trial and marketing authorization applications and combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured and/or distributed to meet required legislation worldwide.
- Lead all aspects of regulatory submissions relevant to assigned projects and programs, in accordance with submission and approval requirements. Lead functional groups across the organization in the development of relevant data to complete regulatory submissions.
- Lead the preparation and maintenance of Clinical Trial Application dossiers, e.g. Investigational New Drug (IND) and Investigational Medicinal Product Dossiers (IMPDs) as applicable.
- Lead the filing teams and assist with preparation and maintenance of product authorization applications, e.g. MAA, BLA as applicable.
- Monitor applications under regulatory review; communicate application progress.
- Lead responses to objections/questions issued by Regulatory Authorities/Agencies.
- Lead preparation, submission and follow-up of Orphan Drug Applications, Pediatric Study Plans, Pediatric Investigational Plans, etc.
- Report adverse events and other unanticipated problems to regulatory agencies and internal stakeholders.
- Responsible for accuracy and content of communications
- Support the preparation, review, and approval of compliant regulatory documents throughout the product lifecycle.
- Provide regulatory guidance to cross-functional teams for project and product lifecycle planning.
- Work effectively with regulatory colleagues specializing in other functional areas to continuously improve regulatory systems, teamwork, and efficiency.
10% Other projects and duties as may be required
Technical Experience and Skills
Managerial Experience and Skills
Learn more here
Job posted: 2020-12-16