Regulatory Specialist
Posted on :
15-08-2024
Employer Active
1 Vacancy
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Job Description
- At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
Qualifications
- University degree from reputable universities (Preferably from Pharmacy, Chemistry, Chemical Engineering, Biology departments)
- Advanced command of written and spoken English,
- Preferably regulatory work experience in a pharmaceutical company:
- Min 1 year of Regulatory Affairs experience for Specialist position
- Min 4 years of Regulatory Affairs experience for Executive position
- Advanced knowledge in MS Office applications,
- High interpersonal, communication and presentation skills,
- Good at teamwork,
- Good at follow-up and strong planning skills,
- No restriction for travel,
- No military obligation for candidates.
- Job Description
- Preparation of registration and variation files according to current Ministry of Health requirements,
- Approval of registrations and sales Permissions,
- Preparation of SmPC/PIL submissions,
- Manage the written correspondence with Ministry of Health before and after registration approval,
- Follow up global and local regulatory requirements,
- Maintain and update global and local regulatory systems.
Employment Type
Full-time
Department / Functional Area
Key Skills
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