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Sr. Manager, Global Regulatory Affairs, Oncology

Global Regulatory Affairs is actively involved in the development and life-cycle management of medicinal products thereby contributing to appropriateness of the drug development path as well as to compliance with applicable pharmaceutical legislation / regulation.

 In this role you will support the preparation and execution of global regulatory strategies and to manage the submission and approval of applications for clinical trials, marketing applications or other related regulatory submissions (e.g. orphan designation, annual report, pediatric plans, DSUR).

 

 Your Role:

  • Manage the regulatory submission including management and coordination of the preparation of all regulatory documentations at different Regulatory milestones
  • Manage the regulatory agency interactions, document preparation, co-ordination rehearsals and minutes (under supervision of a Therapeutic Area Head or Regulatory Strategist)
  • Contribute to the development and evaluation of regulatory strategies for projects
  • Review and provide regulatory comments to quality-, safety- and efficacy or labeling related documents (e.g. protocols, reports) to be included in a regulatory submission (e.g. Clinical Trial Applications, IND, Scientific Advice, HA interactions, Answers to Authorities, PIP/PSP, ODD, DSUR…)
  • Contribute to the development of risk assessment pertaining to the quality-, safety- and efficacy documentation/data of investigational medicinal products related applications

 Who You Are:

  • Degree in Life Science or related discipline, higher degree preferable (Pharm.D., MSc, PhD, MBA) 
  • Minimum of 5 years’ regulatory experience
  • Experience with preparation and writing regulatory documentation to support agency interactions
  • Experience with the clinical trial phase of development, e.g. IND / CTA / eCTD requirements
  • Experience with maintenance of regulatory authorizations in at least one region
  • Experience with supporting a project with development activities in at least one region
  • Experience in oncology preferred
  • Excellent written and spoken communication skills
  • Good interpersonal skills
  • Attention to detail
  • Ability to work in teams
  • Strong organizational and planning skills
Job Requisition ID:  187468
Location:  Billerica
Career Level:  D - Professional (4-9 years)
Working time model:  full-time


Nearest Major Market: Boston

Job Segment: Oncology, Medical, Manager, Pediatric, Pharmaceutical, Healthcare, Management, Science

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