Associate Director Global Regulatory Affairs Oncology
Associate Director Global Regulatory Affairs Oncology
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Salary Not Disclosed
1 Vacancy
Job Description
Global Regulatory Affairs Oncology is actively involved in the development and lifecycle management of medicinal products thereby contributing to appropriateness of the drug development path as well as to compliance with applicable pharmaceutical legislation / regulation this role you will support the preparation and 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 coordination 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 of8 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
Required Experience:
Exec
Employment Type
Full Time
