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.
- Manage all aspects of regulatory submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements.
- Lead 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.
- Manage activities to maintain regulatory filings including planning and preparing BLA amendments, IND/CTA amendments, annual reports, DSURs etc.
- Lead the development of briefing documents for formal regulatory meetings.
- Provide regulatory guidance to cross-functional teams.
- Anticipate regulatory obstacles and emerging issues, including changing regulations, throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
- Initiate and contribute to local process improvements which impact various functional groups
- Develop and maintain cooperative relationships as the point of contact with partners and regulatory health authorities
- Contribute to the development of ex-US regulatory submissions
- Manage the development of regulatory processes to manage pre-approval compliance activities.
- Support the development of regulatory processes for submission planning and management.
- Other projects and duties may be required
- BS in Life/Health Sciences required, graduate degree preferred.
- Minimum 4-6 years experience in Regulatory Affairs or 2-4 with a MS/PhD.
- Pharmaceutical or related environment with biologics experience preferred.
- Working knowledge of all FDA requirements pertaining to submission of regulatory documents
- Demonstrated ability to coordinate submissions independently in a time intensive situation
- Knowledge of the drug development process, with a focus on IND/CTA and BLA/MAA processes.
- Demonstrated experience in preparing IND and/or BLA submissions is required.
- Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents.
- Current knowledge and understanding of GxPs (GCPs, GLPs, GMPs) and ICH guidelines as well as FDA, international, and, if applicable, local regulations.
- 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 excellent verbal and written communication skills.