Senior Director or Vice President of Regulatory Affairs

Job overview

The Senior Director or Vice President of Regulatory Affairs role is onsite four days per week in Brighton, MA. Compensation is not specified in the structured pay fields. Compass Therapeutics’ mission is to bring transformative oncology therapies to patients.

What you'll do

• Lead company regulatory strategy and the Regulatory function
• advise executive leadership
• develop US and international strategies across the pipeline
• lead regulatory planning and readiness for the tovecimig BLA
• coordinate IND and BLA submissions and agency interactions
• establish program plans, timelines, milestones, and budgets
• oversee submission workflows and document governance
• monitor regulatory changes
• manage external consultants and vendors
• and mentor teams on regulatory expectations.

What we're looking for

Skills & competencies

senior director

vice president

regulatory affairs

brighton ma

compass therapeutics

full-time

onsite 4 days/week

oncology

bla submissions

ind submissions

fda

ema

Work arrangement

• Weekend coverage required

Benefits & perks

• Discretionary bonus and equity participation
• medical, dental, and vision premiums
• health reimbursement arrangement
• flexible spending accounts
• gym membership
• employee assistance program
• life insurance
• 401(k) and Roth 401(k) with 6% company match
• parking and commuter reimbursement
• vacation and leave policies
• summer Fridays
• winter shutdown week
• training and tuition reimbursement.

Why this role

The role reports to the CMO and leads regulatory strategy and cross-functional readiness for the tovecimig BLA.

About the employer

Compass Therapeutics is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.