Regulatory Affairs Specialist for Oncology Project Development and Registration
il y a 3 semaines
About the Job
We are seeking an experienced Regulatory Affairs Specialist to contribute to the implementation of our regulatory strategy for the development and registration of oncology projects.
Responsibilities
- Develop and implement regulatory strategies for oncology products, evaluating local and global options.
- Contribute to the development and registration strategy for oncology products, including the construction of the global development plan.
- Prepare and review regulatory documents, including authorization and follow-up of clinical studies.
- Organize and manage meetings with local or global competent authorities.
- Participate in due diligence for new partnerships in oncology.
- Provide advice and opinions on product candidates for licensing-in.
- Contribute to the regulatory analysis of product candidates for licensing-in.
- Review and prepare relevant parts of licensing agreements.
Requirements
- Pharmacist PhD or Masters in Pharmacy/Bachelor in Pharmacy.
- 5 years of experience in Regulatory Affairs strategy/Drug development Plan, experience in oncology preferably.
- Good scientific writing skills.
- Fluent in English and French for daily communication.
- Strong knowledge of RA early phase Drug development with track records in EU.
- Team player with excellent organizational skills.
- Ability to work both independently and in a team environment.
About ProductLife Group
ProductLife Group is a leading company in the development and registration of oncology products. We are committed to bringing innovative solutions to the market and are seeking a skilled Regulatory Affairs Specialist to join our team.
How to Apply
Please submit your application, including your resume and a cover letter, to [insert contact information].
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