- Prepare study documentation for submissions to regulatory authorities in Japan e.g. CTN. Will take ownership for specific pieces of work and may be the Regulatory Submissions lead for projects.
- Review/summarize scientific/research documents in preparation for submission to Regulatory Authorities in Japan.
- Assist in the coordination, collection and organization of data and information required by Regulatory Authorities.
- Responsible for maintaining awareness of regulatory legislation, guidance and practice
pertaining to assigned product/project areas as well as company and client SOPs.
- Assure compliance with regulatory requirements in relation to assigned projects.
- articipate in project development and regulatory strategy planning sessions. Will participate independently in client meetings and will proactively liaise with clients on regulatory submission issues.
- Work on special regulatory projects as assigned.
Bachelor’s Degree in Life Sciences or equivalent
Minimum of 3 years experience in the Pharmaceutical industry in Regulatory Affairs or Drug
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