¨ Assist in the preparation of routine submissions filed to Regulatory Authorities (e.g. INDs/CTAs and NDAs/MAAs/CTDs). May take ownership of specific pieces of work.
¨ Assist in the coordination, collection and organization of data and information required by Regulatory Authorities.
¨ Assist in client meetings and proactively liaise with clients on Regulatory Submission issues.
¨ Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions.
¨ Maintain knowledge and awareness of regulation and guidelines pertaining to drugs and biologics.
¨ Monitor compliance with regulatory requirements in relation to assigned projects.
¨ Work on special regulatory projects as assigned.
Bachelor's or Master's Degree in Life Sciences or equivalentExperience:
4+ years of experience working for US and Canada submissions (preferably US IND, HC CTA)
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