Director, Submission Sciences (regulatory Operations) - Remote

Bilbr

Cambridge, MA, United States
Base: $202,000.00-$278,000.00; bonus/equity: short...
Ectd publishing software experience
Global regulatory submissions
Ich, fda, and ema guidelines
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, including people leadership and financial responsibilities.
  • Biogen offers a full and highly competitive range of benefits designed to support employees' physical, financial, emotional, and social well-being, including medical, dental, vision, and a 401(k) program with company match.

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

Base: $202,000.00-$278,000.00; Bonus/Equity: short term and long-term incentives, cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, & Life insurances, Fitness & Wellness programs, Disability insurance, paid vacation, holidays, sick time, parental leave, 401(k) match, ESPP, tuition reimbursement

Skills & Requirements

Must-have

  • eCTD publishing software experience
  • global regulatory submissions
  • ICH, FDA, and EMA guidelines
  • Regulatory Processes and Systems
  • operational leadership

Nice-to-have

  • influencing without authority
  • energetic and motivated professional
  • pioneering spirit
  • commitment to excellence

Key Requirements

  • Bachelor’s Degree (life sciences preferable)
  • 10-15 years hands-on publishing for IND/CTA/BLA/MDA/MAA
  • 10-15 years experience in Regulatory Operations
  • SME in ICH, FDA, and EMA guidelines
  • Ability to lead within matrix

Work Rights

Not specified

Tailored Resume

Cover Letter