Associate Director, Global Regulatory Affairs, Oncology

Merck KGaA Darmstadt, Germany

Billerica, MA, USA

Full time

Customs and Trade Compliance


Sep 5

Global Regulatory Affairs, Oncology 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:

Minimum Qualifications:

  • Bachelors Degree in Life Science or related discipline.
  • Minimum of 8 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

Preferred Qualifications:

  • Higher degree preferable (Pharm.D., MSc, PhD, MBA) 
  • Experience in oncology strongly preferred
  • Excellent written and spoken communication skills
  • Good interpersonal skills
  • Attention to detail
  • Ability to work in teams
  • Strong organizational and planning skil

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