Advanced medical related graduate degree, such as: pharmacy, nursing with advanced clinical specialty Clinical Nurse Specialist, Nurse Practitioner, PhD with 1-3 years experience in related scientific field.
The Specialist, Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet companys and health authorities’ requirements.
Clinical Data Analyst works under guidance and supervision of their Line Manager and/or Subject Matter Experts to perform some of the clinical data cleaning activities on assigned projects, commensurate with experience and, or project role.
Post-graduate degree in Life Science from a recognized university. Proven and excellent written and verbal communication skills in English, with proven ability to write different types of content for a diverse audience.
Bachelors degree in a scientific, health, communications, technology health related field. Demonstrated experience in technical/ regulatory scientific writing.
Doctoral Degree in Science from a recognised university or equivalent in Biochemistry, Biotechnology, Stem Cell Biology and Neurobiology, Neuroscienc e with a strong publication record and research experience in Cell Biology, Molecular Biology and Neurobiology.
Preparation of original DMF, amendments, Annual reports and Review of adequacy of documents for submission. Compilation, review and submission of various Drug master files for US, EU, TGA, Canada and other markets as per respective regulatory guidelines and checklist
Maintaining detailed records of studies as per FDA and other required guidelines, including things such as drug administration and subject specific case report forms.
Doctoral Degree in Science from a recognized university or equivalent in Biochemistry, Biotechnology, Stem Cell Biology and Neurobiology, Neuroscienc e with a strong publication record and research experience in Cell Biology, Molecular Biology, and Neurobiology.