Celldex Therapeutics

Director / Senior Director, Regulatory Affairs

US-NJ-Hampton | US-MA-Needham | US-CT-New Haven

Overview

The Director / Senior Director, Regulatory Affairs will support Celldex’s development programs by defining and implementing the clinical and nonclinical regulatory strategy for oncology development programs, including defining the regulatory risks and managing the cross functional teams to deliver regulatory submissions and documentation of the highest quality, accuracy and compliance.  The successful candidate must be exceptionally organized and pay keen attention to detail. The position also requires excellent written and verbal communication skills.  Additionally, they must be able to handle tight deadlines and a fast-paced work environment.  Preferred location is Hampton, NJ, with Needham, MA  or New Havin, CT as an optional locations.  Remote may also be considered.

Responsibilities

  • Represent the regulatory function on cross-functional project development teams
  • Provide regulatory guidance and strategy for clinical and nonclinical development including identifying and assessing regulatory risks
  • Manage the clinical and nonclinical regulatory aspects of products and projects including achievement of timelines and deliverables
  • Organize and oversee the preparation and review of health authority submissions (including FDA, EMA and other national authorities) to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA) and serve as primary liaison with regulatory authorities for project clinical and nonclinical activities
  • Lead and deliver through team collaboration meeting requests and briefing documents. Organize preparation of teams for meetings and interface with regulatory authorities
  • Coordinate and prepare responses to requests for information from health authorities
  • Lead regulatory clinical and nonclinical activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
  • Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements through collaboration with responsible line functions
  • Apply for all necessary approvals and marketing permits from the FDA as well as international regulatory offices, and track, obtain and renew any required permits and licenses
  • Monitor, analyze, and disseminate intelligence on regulatory policy and guidelines and make recommendations for impact to projects or organizational practices
  • Train and mentor other regulatory affairs personnel

Qualifications

  • PhD or PharmD in a scientific discipline preferred
  • 10 years of experience in industry related Oncology Regulatory Affairs
  • Knowledge and understanding of FDA and ICH regulations and guidelines is required
  • Demonstrated success in the preparation and submission of INDs
  • Experience in attending and leading a team to prepare for health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings etc.) is desirable
  • Knowledge and understanding of global development and previous experience with other authorities is desirable
  • Ability to work in a cross-functional team environment with successful ability to manage project teams
  • Keen attention to detail and the ability to handle multiple tasks and manage a dynamic work environment
  • Strong organizational, computer and documentation skills and an ability to prioritize effectively
  • Excellent interpersonal skills.   Both verbal and written communication are also essential in this collaborative work environment, and to interact effectively with regulatory authorities

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