Regulatory Affairs US Regulatory Lead- REMOTE EST (hybrid Boston, MA preferred) Massachusetts
Orbis Clinical is seeking a US Regulatory Lead located in Boston, MA (HM may allow fully remote based TBA) for 6 months with potential for extension but not guaranteed.
Job Title: US Regulatory Lead
Location: Boston, MA
**hybrid Boston, MA strongly preferred but also open to strong remote based candidates within the east coast time zone.
Contract: 6 months (potential for extension or conversion (not guaranteed))
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
Compensation Details:
- Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
- The Pay Range for this position is $101.00 – $121.00 per hour, can vary depending on employment status.
- Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k).
EEO and Reasonable Accommodation Statement:
Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.
By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.
