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Associate Director, Global Regulatory Affairs Strategy, Oncology

Location
Billerica, Massachusetts
Job Type
Permanent
Posted
13 Oct 2020

In the Global Regulatory Affairs, Oncology group you will be 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.

Your Role

As the Associate Director you will function as a Regional lead and Health Authority liaison, responsible for preparation and execution of regional regulatory activities and submissions, and to contribute to the regulatory strategies for supporting clinical trials, marketing applications or other related regulatory submissions (orphan designation, annual report, pediatric plans and DSUR etc.)

  • Manage Health Authority communications including coordination of the preparation of all regulatory documents at different regulatory milestones; coordination of meeting activities including rehearsals and minutes (under supervision)
  • Contribute to development and evaluation of regulatory strategies for projects (under supervision)
  • 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

Minimum Qualifications:

  • Bachelors degree
  • Minimum of 5 years' relevant regulatory experience in Oncology
  • Experience with preparation and writing regulatory documentation to support agency interactions (FDA)
  • Experience in IND / CTA / eCTD requirements
  • Knowledge of regulatory affairs applicable to location of residence (US and EU)
  • Experience with maintenance of regulatory authorizations
  • Experience with supporting a project with development activities
  • Excellent written and spoken communication skills

Preferred Qualifications

  • Advanced degree preferable (Pharm.D., MSc, PhD, MBA)
  • Good interpersonal skills
  • Attention to detail
  • Ability to work in teams
  • Strong organizational and planning skills

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Details

  • Job Reference: 181963206-2
  • Date Posted: 13 October 2020
  • Recruiter: Millipore Corporation
  • Location: Billerica, Massachusetts
  • Salary: On Application
  • Sector: Government & Defence
  • Job Type: Permanent