Senior Regulatory Affairs Specialist
Há 3 dias
We are seeking a skilled Regulatory Affairs Specialist to join our team.
The ideal candidate will have experience in preparing submissions for sophisticated devices and a successful track record.
- Actively participate in RA teams to achieve common goals or attend common strategies.
- Prepare registration dossiers for new product introductions, developments, changes, and renewals.
- Review and assess documentation to ensure accurate interpretation of country regulations.
- Supervise and analyze country requirements to identify trends and changes in regulation.
- Consult with partners regarding submission requirements and standards to facilitate efficient processing by health authorities in multiple countries.
- Serve as a subject matter expert on documentation and regulation before operating companies to ensure understanding of country regulation needs.
- Implement results-oriented Regulatory Affairs strategies.
Key Responsibilities:
The selected candidate will possess a strong background in regulatory affairs and excellent communication skills.
A Bachelor's Degree in Engineering, Pharmacy, or other life science is required. 3-4 years of experience working in the Regulatory Environment, preparing submissions for sophisticated devices, and a successful track record are necessary.
Desirable experience in Medical Devices and Pharma backgrounds are acceptable.
Requirements:
BA/BS degree in Life Science field such as Biology, Chemistry, Biochemistry, etc.
Minimum 3 years of experience in Regulatory Affairs within the pharmaceutical industry.
Expert knowledge of GxP regulations.
Strong analytical and problem-solving skills.
Excellent written and verbal communication skills.
Ability to work independently and collaboratively as part of a global team.
Detail-oriented and organized with high level of accuracy.
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