PREREQUISITES

BS/BA degree in Scientific Discipline (Masters or higher preferred) with 8-10 years in the pharmaceutical industry or in CRO, including 5-7 years CMC regulatory small molecule experience.

Responsibilities will include, but are not limited to, the following:

Responsible for the development of the CMC regulatory strategy for our submissions. These submissions include Health Authority Briefing Packages/IND regulatory filings. Prepare, coordinate and review CMC submission documents, registration dossiers, and responses to health authorities with other relevant line functions. Responsible for the regulatory evaluation of CMC change controls. Responsible for the management of CMC activities related to specific developmental or commercial compounds. Represent Regulatory CMC on CMC development/commercial and Regulatory Affairs teams.

In addition, take on leadership role in the CMC development/commercial teams. Interact with regulatory agencies and represent CMC at regulatory agency meetings.

Skills/Knowledge Required:
? Must have experience with CMC regulatory documents (e.g. MAA, CTD, supplements, responses), with specific emphasis on IND/IB in the USA and China; Experience in EOP2 and NDA CMC regulatory document preparation is a plus.
? Experience in the development of CMC regulatory strategy for clinical candidates
? Knowledge of FDA, EMA and ICH guidelines.
? Interaction with regulatory agencies
? Have a solution-oriented approach to problem solving
? Expertise in either the drug discovery, preclinical development process
? Ability to work on complex projects and multi-discipline cross-functional teams
? Prior working experiences with CROs
? Experience with CMC regulations for compounds.

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