We are seeking a Regulatory Affairs Consultant to work on a remote team for a client project. Our client is located in Boston and therefore is requiring the hours worked to be in the Eastern Time Zone. The position is slated to run for at least 6 months and can be extended.

No 3rd party candidates will be considered for this role.

Primary Responsibilities

• Collaborates with and assists other US Regulatory Leads with project deliverables, preparing for FDA meetings, conducting regulatory research, regulatory intelligence, and/or preparing slides on regulatory topics
• May serve as US Regulatory Lead for new products or new indication expansions for marketed products
• Represents US Regulatory function in various cross functional teams (for example, clinical study teams, oncology-specific workgroups, global regulatory team for newly assigned programs, etc.)
• Responsible for IND/NDA/BLA submissions and collaborates with assigned resource for maintenance activities
• Coordinates mapping and authoring of end-to-end process descriptions for specific types of regulatory submissions
• May assist with US regulatory assessment of external innovation opportunities

Education and Required Skills

• BS/BA in relevant scientific discipline, advanced degree is a plus
• Knowledge and experience of US FDA regulatory requirements and submissions, including filing of IND/NDA/BLA to FDA
• 7-10 years Regulatory Affairs experience, more experience preferred

Travel and Location

• Little to no travel is expected
• This role is 100% remote

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.