Executive Director, Regulatory Affairs

Boston Permanent USD200,000 - USD220,000
  • Join a biotech company developing medicines for devastating diseases
  • Exciting opportunity to serve as lead of Regulatory

About Our Client

A clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases.

Job 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
  • Serve as the regulatory point of contact to the project team and regulatory authorities for assigned projects.
  • Lead development and strategy of regulatory documents submissions to CTAs, INDs, NDAs/BLAs, and MAAs
  • Lead interactions with regulatory authorities
  • Ensure timely communication of relevant program topics and issues to regulatory affairs management and PureTech leadership.
  • Ensure compliance with all internal and external requirements and procedures and may suggest improvement to operating policies/processes, as appropriate.
  • Lead, manage, mentor, and develop direct reports including goal setting and performance management.
  • Ensures that adequate regulatory resources (internal and external) are planned and allocated to ensure on time and quality regulatory submissions.
  • Identifies and leads initiatives to improve processes and procedures in the regulatory affairs department.
  • Other duties as required



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

  • BS Degree. Advanced degree, such as PhD, PharmD, or MS in regulatory affairs is preferred
  • 12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or clinical drug development experience.
  • Experience in reviewing, authoring, or managing components of regulatory submissions.
  • Experience with leading major drug development interactions with regulatory authorities
  • Prior experience working in rapidly growing pharmaceutical organizations is desirable

What's on Offer

  • Competitive compensation and benefits
  • Opportunity to lead Regulatory team and support Head of Regulatory
Contact
Meghan Landry
Quote job ref
JN-042022-5427140

Job summary

Sector
Life Sciences
Sub Sector
Biotechnology
Industry
Healthcare / Pharmaceutical
Location
Boston
Contract Type
Permanent
Consultant name
Meghan Landry
Job Reference
JN-042022-5427140