Director, Global Regulatory Affairs

Watertown Permanent USD200,000 - USD250,000 per year Hybrid working
  • Rapidly growing, well-financed biotech organization focused on orphan drugs
  • Opportunity to own and develop global regulatory strategy for program pipeline

About Our Client

Our client is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of orphan drugs for patients with hematologic disorders.

Job Description

  • Define the company regulatory strategy for the biologic and small molecule programs
  • Oversee regulatory matters and drive regulatory strategy
  • Author, review, and/or approve documentation, regulatory strategies, and global content for relevant submissions and programs
  • Coordinate and manage global regulatory affairs submissions to ensure compliance to regulatory expectations and adherence to relevant internal Standard Operating Procedures
  • Perform technical reviews to ensure quality Regulatory Affairs submissions

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • BA/BS required, Ph.D. or other degree preferred
  • A minimum of 8 years total pharmaceutical/related industry experience required
  • A minimum 6 years regulatory experience
  • Knowledge of FDA drug and biologics regulations
  • Experienceworking with international regulators
  • EU regulatory experience preferred
  • Experience with product labelling strategy
  • Familiarity with ICH guidelines for development programs
  • Experience working on project teams is required

What's on Offer

  • Competitive base salary + benefit package
  • Opportunity for career advancement and development
  • Opportunity to own organization's regulatory strategy
  • Work on diverse product pipeline moving through to commercialization
  • Remote flexibility
Samantha Kidd
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Job summary

Life Sciences
Sub Sector
Regulatory Affairs
Healthcare / Pharmaceutical
Contract Type
Consultant name
Samantha Kidd
Job Reference
Job Nature
Hybrid working