Title : Senior / Executive Director Regulatory Affairs
The experience expected from applicants, as well as additional skills and qualifications needed for this job are listed below.
Summary : A growing immune-oncology company is seeking a Senior / Executive Director of Regulatory Affairs to join the team in executing regulatory strategies and supporting the development of their product pipeline with an emphasis on early stage development.
The S / E Director of Regulatory Affairs will be responsible for :
- Providing regulatory leadership and guidance to project teams and work collaboratively with cross functional teams
- Lead regulatory strategy, provide regulatory guidance / precedents; identify, assess, and mitigate regulatory risks
- Monitor regulatory agency activities in the relevant space and maintain a global perspective on regulatory strategy
- Prepare and lead teams in regulatory meetings and interactions with notified bodies
- Lead the authoring and review of regulatory documents in a timely manner
- Lead department initiatives and assist in training and oversight of the RA team
Qualifications :
- 10+ years in Regulatory Affairs in biopharma industry or equivalent
- Extensive experience of regulatory requirements and early to late-stage experience with US, EU, and RoW submissions for therapeutic products and IVDs (IDE / IND / CTA / BLA / NDA)
- Ability to develop and implement regulatory strategies in the Oncology field
- Experience working with regulatory agencies and effectively move products through the development process
- Highly collaborative working style with the ability to work in cross-functional
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