Associate Director, Regulatory Affairs

Boston Permanent USD140,000 - USD160,000
  • Opportunity to join a rapidly growing and publicly traded biotech organization
  • Work on extremely diverse and robust product pipeline

About Our Client

Our client is an exciting and disruptive clinical stage biotech company with a wide pipeline focused on developing treatments for inflammatory conditions, cancers, and respiratory and lymphatic diseases, among others.

Job Description

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.

Description

  • Proactively develop and execute creative and thorough global regulatory strategies for assets in clinical development through collaborative partnership and regulatory leadership within the project team
  • Ability to assess and develop solutions for complex regulatory challenges
  • Function as a strategic regulatory partner within the cross-functional project team to execute on program strategies and deliverables
  • Server as the regulatory point of contact for assigned projects.
  • Support and lead development and strategy of regulatory documents submissions to CTAs, INDs, NDAs/BLAs, and MAAs
  • Support and lead interactions with regulatory authorities
  • Ensure timely communication of relevant program topics and issues to regulatory affairs management.
  • Ensure compliance with all internal and external requirements and procedures and may suggest improvement to operating policies/processes, as appropriate.

The Successful Applicant

* Advanced degree in regulatory affairs is preferred

* 6 yearsof regulatory affairs experience within the pharmaceutical prescription drug industry.

* Demonstrated ability to coordinate the development of regulatory documents involved in the approval of prescription drugs with a focus on FDA and EMA

* Experience with supporting and leading interactions with regulatory authorities

What's on Offer

  • Highly competitive base salary and benefit package
  • Opportunity to drive Regulatory strategy at rapidly growing organization
  • Career growth and professional development
  • Opportunity to work fully remote
  • Opportunity to work on extremely diverse and robust product pipeline
Contact
Moriah Sweeney
Quote job ref
JN-022022-5285343

Job summary

Sector
Life Sciences
Sub Sector
Biotechnology
Industry
Healthcare / Pharmaceutical
Location
Boston
Contract Type
Permanent
Consultant name
Moriah Sweeney
Job Reference
JN-022022-5285343