Global Regulatory Sciences Manager

Job Title: Global Regulatory Sciences Manager
Location: Cambridge, MA 02139
Duration: 6 Months+ (Temp to Perm Opportunity)
 
Shift: Standard Business Hours, Hybrid Schedule
Pay Rate: $70 – $75/hr. on W2
 
Position Summary:
As a Manager in the Global Regulatory Sciences team, this role supports and implements global regulatory strategies for the company’s mast cell disease portfolio. Reporting to the Director of Global Regulatory Sciences, this individual provides both strategic and operational regulatory support for cross-functional teams responsible for the development, registration, and maintenance of compounds. This includes collaboration with external partners and regulatory authorities.
 
Responsibilities:

• Support line manager in daily regulatory aspects of at least one clinical development program.
• Responsible for relevant submissions for assigned program(s).
• Represent Global Regulatory Sciences on cross-functional teams.
• Support line manager in developing and implementing long- and short-term product regulatory strategies/plans.
• Lead preparation efforts for health authority meetings.
• Provide guidance to external vendors and consultants.
• Monitor evolving regulatory requirements and advise teams on impact.

 
Qualifications:

• Bachelor’s degree in a scientific discipline; advanced degree a plus.
• 4+ years in drug development; direct regulatory experience preferred.
• Experience in oncology or rare diseases drug development a plus.
• Experience filing and managing INDs with FDA preferred.
• Working knowledge of U.S. drug development and regulatory requirements.
• Knowledge of EU, Canada, ROW, and post-marketing regulatory requirements is a plus.

 
Capabilities:

• Excellent interpersonal and communication skills.
• Well-organized and detail-oriented; able to manage multiple deliverables.
• Effective collaborator with strong listening and engagement skills.
• Flexible and adaptable in ambiguous situations.
• Proficient in Microsoft Word, Excel, PowerPoint, SmartSheet, and Adobe Acrobat.
• Results-driven mindset with strong accountability.