Director, Submission Sciences (regulatory Operations)

Biogen

Cambridge, MA, United States
$202,000.00-$278,000.00; bonus/equity: cash bonus ...
Ectd publishing software experience
Global health authority guidelines
Regulatory process improvement initiatives
The Director of SABR Submissions Sciences is responsible for leading the Global Delivery Management (GDM) function, which delivers timely and quality submissions to global regulatory authorities

Job Summary

  • The Director of SABR Submissions Sciences is responsible for leading the Global Delivery Management (GDM) function, which delivers timely and quality submissions to global regulatory authorities.
  • This role provides strategic leadership, optimizes resource allocation, develops initiatives, and drives operational excellence for the entire GDM function.
  • Biogen offers a full and highly competitive range of benefits designed to support employees' and their families physical, financial, emotional, and social well-being.

Matching Summary

The Director of SABR Submissions Sciences is responsible for leading the Global Delivery Management (GDM) function, which delivers timely and quality submissions to global regulatory authorities.

Salary

$202,000.00-$278,000.00; Bonus/Equity: Cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, Life insurances, Fitness & Wellness programs, Disability insurance, Paid time off, Holidays, Paid Maternity and Parental Leave, 401(k) with match, ESPP, Tuition reimbursement

Skills & Requirements

Must-have

  • eCTD publishing software experience
  • Global Health authority guidelines
  • Regulatory process improvement initiatives
  • People leadership and development
  • Financial acumen and budget management

Nice-to-have

  • Influencing without authority
  • Pioneering spirit and commitment to excellence
  • Building trusted cross-functional relationships

Key Requirements

  • Bachelor’s Degree (life sciences preferable)
  • 10-15 years publishing for IND/CTA/BLA/NDA/MAA
  • 10-15 years Regulatory Operations experience
  • SME in ICH, FDA, and EMA guidelines
  • Experience with Regulatory Processes and Systems

Work Rights

Not specified

Tailored Resume

Cover Letter