• Full Time (Salaried)
  • Boston, MA

Company:  Confidential

Job Title: Senior Director, Regulatory Affairs

Job Number: 24996

Location: Boston, MA

Job Description

In this Regulatory Affairs role, the Senior Director will need to be resourceful, collaborative, versatile and highly knowledgeable in regulatory strategy, interactions, and submissions.  The candidate must be comfortable working with cross-functional teams. Reporting to the Chief Medical Officer, this person will provide strong operational regulatory expertise and lead strategic regulatory initiatives associated with Fusion's product candidate development.  The candidate should also have 5+ years of regulatory experience in oncology drug development including global regulatory submissions and interactions.

Responsibilities

  • Serve as regulatory leader for regulatory filings
  • Serve to represent regulatory on cross-functional teams
  • Work on complex problems, propose solutions, and drive execution related to product development from Phase1 through approval
  • Review documents and provide regulatory guidance for clinical protocols, investigator brochures, informed consents, and other GCP documentation
  • Prepare and oversee clinical trial applications, amendments, meeting briefing documents, and applications for orphan drug or special status
  • Work with Regulatory Operations to ensure e-submissions are complete and technically compliant in accordance with eCTD specifications
  • Serve as regulatory lead and primary point of contact for CMC team interactions with regulatory agencies
  • Oversee the preparation, submission and file maintenance for submissions
  • Work with Clinical Team to review and contribute to IB updates
  • Lead/draft Development Safety Update Safety Reports (DSURs)
  • Interact with global partners for combination therapy regulatory matters
  • Align with pharmacovigilance for safety reviews and core data maintenance
  • Establish or re-engineer SOPs, as needed
  • Monitor and communicate regulatory changes and enforcement activities
  • Estimate resource needs and identify, onboard, and manage resources
  • Provide research and information for regulatory affairs budgeting
  • Other responsibilities, as required

Required Skills

Candidate Must:
The candidate must thrive in a fast-paced environment that requires sound judgement, effective and proactive communication and transparency amongst employees. The successful candidate must: 

  • Embrace collaboration across departments
  • Be an excellent communicator both verbally and in writing
  • Be an independent contributor who proactively shares and collaborates
  • Effectively identify, prioritize and solve problems
  • Effectively recommend and implement solutions to problems
  • Understand and be able to articulate examples for how quality is essential to drug development 
  • Effectively use MS Word, Excel, flowcharting programs, PowerPoint

 
Qualifications:

  • Bachelors' degree and at least 8 years direct, progressively responsible, regulatory affairs experience, of which at least 4 must involve clinical development
  • Minimum of 4 years regulatory experience with biotechnology products that are in Phase 1-3 development; experience with oncology products is required
  • US IND preparation experience 
  • Experience with global applications and change control
  • Excellent writing skills
  • Demonstrated project management skills and organizational skills
  • Self-motivated and proactive work style with the ability to initiate and follow through on assignments

 

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