Associate Director, Regulatory Affairs

Job overview

The Associate Director, Regulatory Affairs role is onsite in Cambridge, MA. Pay is $170,000–$195,000 per year, with an annual target bonus and equity also described. Parabilis Medicines is a clinical-stage biopharmaceutical company developing medicines for serious diseases, including oncology and rare disease programs.

What you'll do

• Contribute to global regulatory strategies and provide tactical guidance
• support planning for IND, NDA/BLA, briefing package, and orphan drug submissions
• support regulatory consultants and vendors
• serve as a regulatory liaison for health authorities as assigned
• prepare agency meeting materials
• communicate regulatory risks and timelines
• represent Regulatory Affairs on project, clinical, and study teams
• support submission teams
• maintain regulatory SOPs and intelligence
• participate in regulatory due diligence. Travel up to 10%.

What we're looking for

Skills & competencies

associate director

regulatory affairs

cambridge ma

$170k–$195k/year

biopharmaceutical

oncology

rare disease

fda submissions

ind

nda/bla

global regulatory strategy

parabilis medicines

Work arrangement

• Weekend coverage required

Benefits & perks

• Annual target bonus, equity, and a comprehensive benefits package.

Why this role

Supports global regulatory strategy and submissions across oncology and rare-disease development programs.

About the employer

Parabilis Medicines is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.